Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00925587
• Collaborator: (none)
• Enrollment: 358
• Locations: 157
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.

Condition or Disease	Intervention/Treatment	Phase
Anemia; Chronic Kidney Disease	Drug: darbepoetin alfa	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 358 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Q2W Q2W administration of darbepoetin alfa.	Drug: darbepoetin alfa; Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.; Other Names: Placebo
Active Comparator: QM QM administration of darbepoetin alfa	Drug: darbepoetin alfa; Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) [Baseline Week 33]

   The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.

Secondary Outcome Measures

1. Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration. [Baseline to Week 33]

2. Hb at Baseline [Baseline]

3. Hb at Week 3 [Week 3]

4. Hb at Week 5 [Week 5]

5. Hb at Week 7 [Week 7]

6. Hb at Week 9 [Week 9]

7. Hb at Week 11 [Week 11]

8. Hb at Week 13 [Week 13]

9. Hb at Week 15 [Week 15]

10. Hb at Week 17 [Week 17]

11. Hb at Week 19 [Week 19]

12. Hb at Week 21 [Week 21]

13. Hb at Week 23 [Week 23]

14. Hb at Week 25 [Week 25]

15. Hb at Week 27 [Week 27]

16. Hb at Week 29 [Week 29]

17. Hb at Week 31 [Week 31]

18. Hb at Week 33 [Week 33]

19. Darbepoetin Alfa Dose at Week 1 [Week 1]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

20. Darbepoetin Alfa Dose at Week 3 [Week 3]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

21. Darbepoetin Alfa Dose at Week 5 [Week 5]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

22. Darbepoetin Alfa Dose at Week 7 [Week 7]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

23. Darbepoetin Alfa Dose at Week 9 [Week 9]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

24. Darbepoetin Alfa Dose at Week 11 [Week 11]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

25. Darbepoetin Alfa Dose at Week 13 [Week 13]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

26. Darbepoetin Alfa Dose at Week 15 [Week 15]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

27. Darbepoetin Alfa Dose at Week 17 [Week 17]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

28. Darbepoetin Alfa Dose at Week 19 [Week 19]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

29. Darbepoetin Alfa Dose at Week 21 [Week 21]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

30. Darbepoetin Alfa Dose at Week 23 [Week 23]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

31. Darbepoetin Alfa Dose at Week 25 [Week 25]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

32. Darbepoetin Alfa Dose at Week 27 [Week 27]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

33. Darbepoetin Alfa Dose at Week 29 [Week 29]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

34. Darbepoetin Alfa Dose at Week 31 [Week 31]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

35. Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) [Weeks 29-33]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

36. Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 [Week 3]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

37. Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 [Week 5]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

38. Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 [Week 7]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

39. Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 [Week 9]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

40. Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 [Week 11]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

41. Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 [Week 13]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

42. Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 [Week 15]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

43. Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 [Week 17]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

44. Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 [Week 19]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

45. Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 [Week 21]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

46. Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 [Week 23]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

47. Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 [Week 25]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

48. Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 [Week 27]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

49. Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 [Week 29]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

50. Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 [Week 31]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

51. Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) [Weeks 1-33]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

52. Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) [Weeks 1-33]

53. Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) [Evaluation Period]

    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ≥ 18 years of age

• Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)

• Two consecutive screening Hb values taken at least 7 days apart must each be <10.0 g/dL

• TSAT ≥ 15%

Exclusion Criteria:

• Upper or lower GI bleeding within 6 months before enrolment

• ESA use within 12 weeks before enrolment

• Uncontrolled hypertension

• Systemic haematologic disorders

• Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.

• Grand mal seizure within 6 months prior to enrolment

• Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.

• Red blood cell transfusion within 12 weeks prior to enrolment

• Androgen therapy within 8 weeks prior to enrolment

• Pregnancy or breast feeding, or inadequate contraception

• Currently receiving immunosuppressive therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Gosford	New South Wales	Australia	2250
2	Research Site	Liverpool	New South Wales	Australia	2170
3	Research Site	New Lambton	New South Wales	Australia	2305
4	Research Site	Randwick	New South Wales	Australia	2031
5	Research Site	Cairns	Queensland	Australia	4870
6	Research Site	Box Hill	Victoria	Australia	3128
7	Research Site	Footscray	Victoria	Australia	3011
8	Research Site	Parkville	Victoria	Australia	3050
9	Research Site	Reservoir	Victoria	Australia	3073
10	Research Site	Bruxelles		Belgium	1020
11	Research Site	Bruxelles		Belgium	1200
12	Research Site	Edegem		Belgium	2650
13	Research Site	Gent		Belgium	9000
14	Research Site	Leuven		Belgium	3000
15	Research Site	Liège		Belgium	4000
16	Research Site	Roeselare		Belgium	8800
17	Research Site	Pleven		Bulgaria	5800
18	Research Site	Sofia		Bulgaria	1431
19	Research Site	Sofia		Bulgaria	1709
20	Research Site	Varna		Bulgaria	9010
21	Research Site	Brno		Czech Republic	615 00
22	Research Site	Chrudim		Czech Republic	537 27
23	Research Site	Jilemnice		Czech Republic	514 15
24	Research Site	Kladno		Czech Republic	272 59
25	Research Site	Liberec 1		Czech Republic	460 03
26	Research Site	Novy Jicin		Czech Republic	741 01
27	Research Site	Plzen		Czech Republic	301 00
28	Research Site	Praha 10		Czech Republic	100 34
29	Research Site	Praha 4 - Nusle		Czech Republic	140 00
30	Research Site	Praha 4		Czech Republic	149 00
31	Research Site	Praha 6		Czech Republic	160 00
32	Research Site	Praha 6		Czech Republic	169 00
33	Research Site	Praha 8		Czech Republic	181 02
34	Research Site	Slavkov u Brna		Czech Republic	684 01
35	Research Site	Sternberk		Czech Republic	785 01
36	Research Site	Usti nad Orlici		Czech Republic	562 18
37	Research Site	Roskilde		Denmark	4000
38	Research Site	Viborg		Denmark	8800
39	Research Site	Ã…rhus		Denmark	8200
40	Research Site	Tallinn		Estonia	10617
41	Research Site	Tallinn		Estonia	13419
42	Research Site	Annonay		France	07100
43	Research Site	Creil		France	60100
44	Research Site	Grenoble		France	38000
45	Research Site	Metz		France	57000
46	Research Site	Montivilliers		France	76290
47	Research Site	Nice		France	06000
48	Research Site	Poissy		France	78300
49	Research Site	Reims Cedex		France	51092
50	Research Site	Rouen Cedex		France	76031
51	Research Site	Saint Priest en Jarez		France	42270
52	Research Site	Bernkastel-Kues		Germany	54470
53	Research Site	Coesfeld		Germany	48653
54	Research Site	Düsseldorf		Germany	40210
55	Research Site	Hamburg		Germany	22297
56	Research Site	Leverkusen		Germany	51373
57	Research Site	Alexandroupoli		Greece	68100
58	Research Site	Athens		Greece	11528
59	Research Site	Larissa		Greece	41110
60	Research Site	Thessaloniki		Greece	54636
61	Research Site	Thessaloniki		Greece	54642
62	Research Site	Baja		Hungary	6500
63	Research Site	Budapest		Hungary	1115
64	Research Site	Debrecen		Hungary	4012
65	Research Site	Esztergom		Hungary	2500
66	Research Site	Gyor		Hungary	9023
67	Research Site	Kaposvar		Hungary	7400
68	Research Site	Pecs		Hungary	7624
69	Research Site	Szekszard		Hungary	7100
70	Research Site	Szombathely		Hungary	9700
71	Research Site	Zalaegerszeg		Hungary	8900
72	Research Site	Ashkelon		Israel	78278
73	Research Site	Hadera		Israel	38100
74	Research Site	Jerusalem		Israel	91031
75	Research Site	Albano Laziale RM		Italy	00041
76	Research Site	Ancona		Italy	60125
77	Research Site	Cagliari		Italy	09134
78	Research Site	Firenze		Italy	50141
79	Research Site	Lecco		Italy	23900
80	Research Site	Napoli		Italy	80131
81	Research Site	Pavia		Italy	27100
82	Research Site	Roma		Italy	00189
83	Research Site	Torino		Italy	10126
84	Research Site	Torino		Italy	10154
85	Research Site	Daugavpils		Latvia	5417
86	Research Site	Riga		Latvia	1001
87	Research Site	Riga		Latvia	1002
88	Research Site	Riga		Latvia	1038
89	Research Site	Valmiera		Latvia	4201
90	Research Site	Ventspils		Latvia	3600
91	Research Site	Saltillo	Coahuila	Mexico	25230
92	Research Site	Guadalajara	Jalisco	Mexico	44140
93	Research Site	Cuernavaca	Morelos	Mexico	62448
94	Research Site	Queretaro	Querétaro	Mexico	76178
95	Research Site	San Luis Potosi	San Luis PotosÃ-	Mexico	78240
96	Research Site	Choszczno		Poland	73-200
97	Research Site	Golub-Dobrzyn		Poland	87-400
98	Research Site	Koscierzyna		Poland	83-400
99	Research Site	Koszalin		Poland	75-581
100	Research Site	Legnica		Poland	59-220
101	Research Site	Lodz		Poland	90-549
102	Research Site	Lodz		Poland	93-120
103	Research Site	Lublin		Poland	20-954
104	Research Site	Poznan		Poland	61-289
105	Research Site	Warszawa		Poland	04-749
106	Research Site	Zamosc		Poland	87-100
107	Research Site	Evora		Portugal	7000-811
108	Research Site	Faro		Portugal	8000-386
109	Research Site	Lisboa		Portugal	1649-035
110	Research Site	Porto		Portugal	4099-001
111	Research Site	Setúbal		Portugal	2910-446
112	Research Site	Bucharest		Romania	010731
113	Research Site	Bucharest		Romania	014461
114	Research Site	Bucharest		Romania	022328
115	Research Site	Bucharest		Romania	050098
116	Research Site	Iasi		Romania	700503
117	Research Site	Timisoara		Romania	300736
118	Research Site	Ekaterinburg		Russian Federation	620102
119	Research Site	Moscow		Russian Federation	117036
120	Research Site	Moscow		Russian Federation	123183
121	Research Site	Moscow		Russian Federation	125284
122	Research Site	Saint Petersburg		Russian Federation	191104
123	Research Site	Saint Petersburg		Russian Federation	196247
124	Research Site	Saint-Petersburg		Russian Federation	195067
125	Research Site	Belgrade		Serbia	11000
126	Research Site	Krgujevac		Serbia	34000
127	Research Site	Zemun		Serbia	11080
128	Research Site	Bratislava		Slovakia	831 03
129	Research Site	Galanta		Slovakia	924 22
130	Research Site	Namestovo		Slovakia	029 01
131	Research Site	Sala		Slovakia	927 19
132	Research Site	Trstena		Slovakia	028 01
133	Research Site	Zvolen		Slovakia	960 01
134	Research Site	Jesenice		Slovenia	4270
135	Research Site	Novo mesto		Slovenia	8000
136	Research Site	Sempeter pri Gorici		Slovenia	5290
137	Research Site	Slovenj Gradec		Slovenia	2380
138	Research Site	Jaén	AndalucÃ-a	Spain	23007
139	Research Site	Barcelona	Cataluña	Spain	08036
140	Research Site	L'Hospitalet de Llobregat	Cataluña	Spain	08907
141	Research Site	Majadahonda	Madrid	Spain	28222
142	Research Site	Galdakao	PaÃ-s Vasco	Spain	48960
143	Research Site	Madrid		Spain	28046
144	Research Site	Birmingham		United Kingdom	B9 5SS
145	Research Site	Brighton		United Kingdom	BN2 5BE
146	Research Site	Cambridge		United Kingdom	CB2 2QQ
147	Research Site	Coventry		United Kingdom	CV2 2DX
148	Research Site	Glasgow		United Kingdom	G11 6NT
149	Research Site	Hull		United Kingdom	HU3 2JZ
150	Research Site	Leicester		United Kingdom	LE5 4PW
151	Research Site	Newcastle Upon Tyne		United Kingdom	NE7 7DN
152	Research Site	Salford		United Kingdom	M6 8HD
153	Research Site	Shrewsbury		United Kingdom	SY3 8XQ
154	Research Site	Stevenage		United Kingdom	SG1 4AB
155	Research Site	Stoke On Trent		United Kingdom	ST4 7LN
156	Research Site	Swansea		United Kingdom	SA6 6NL
157	Research Site	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00925587
• Other Study ID Numbers: 20060163; 2006-003173-27
• First Posted: Jun 22, 2009
• Last Update Posted: Jun 4, 2014
• Last Verified: May 1, 2014

• Keywords provided by Amgen: CKD; Anemia; correction; darbepoetin alfa
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Darbepoetin alfa

Study Results

Participant Flow

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Period Title: Overall Study
STARTED	178	180
COMPLETED	142	155
NOT COMPLETED	36	25

Baseline Characteristics

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM	Total
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly	Total of all reporting groups
Overall Participants	175	180	355
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.4 (14.1)	66.3 (15.2)	67.3 (14.7)
Age, Customized (Number) [Number]
<65 years	60 34.3%	67 37.2%	127 35.8%
>=65-<75 years	42 24%	54 30%	96 27%
>=75 years	73 41.7%	59 32.8%	132 37.2%
Sex: Female, Male (Count of Participants)
Female	107 61.1%	104 57.8%	211 59.4%
Male	68 38.9%	76 42.2%	144 40.6%
Race/Ethnicity, Customized (Number) [Number]
Black or African American	0 0%	1 0.6%	1 0.3%
White or Caucasian	166 94.9%	163 90.6%	329 92.7%
Other	9 5.1%	16 8.9%	25 7%
Baseline Hemoglobin (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	9.13 (0.61)	9.11 (0.70)	9.12 (0.65)

Outcome Measures

1. Primary Outcome

Title	Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
Description	The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.
Time Frame	Baseline Week 33

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	154
Least Squares Mean (95% Confidence Interval) [g/dL]	2.157	1.969

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Darbepoetin Alfa Q2W, Darbepoetin Alfa QM
	Comments	Power = 90% at sample size calculation
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin -0.5 g/dL
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.188
	Confidence Interval	(2-Sided) 95%; -0.427 to 0.052
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.122
	Estimation Comments	Darbepoetin alfa QM - Darbepoetin alfa Q2W

2. Secondary Outcome

Title	Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.
Time Frame	Baseline to Week 33

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	154
Number (95% Confidence Interval) [Percentage of Participants]	97.9 55.9%	98.1 54.5%

3. Secondary Outcome

Title	Hb at Baseline
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	154
Mean (Standard Error) [g/dL]	9.17 (0.05)	9.12 (0.06)

4. Secondary Outcome

Title	Hb at Week 3
Time Frame	Week 3

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	153
Mean (Standard Error) [g/dL]	9.89 (0.08)	10.13 (0.10)

5. Secondary Outcome

Title	Hb at Week 5
Time Frame	Week 5

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	152
Mean (Standard Error) [g/dL]	10.58 (0.08)	10.28 (0.09)

6. Secondary Outcome

Title	Hb at Week 7
Time Frame	Week 7

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	152
Mean (Standard Error) [g/dL]	10.90 (0.09)	10.75 (0.10)

7. Secondary Outcome

Title	Hb at Week 9
Time Frame	Week 9

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	153
Mean (Standard Error) [g/dL]	11.24 (0.10)	10.79 (0.10)

8. Secondary Outcome

Title	Hb at Week 11
Time Frame	Week 11

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	151
Mean (Standard Error) [g/dL]	11.35 (0.10)	11.17 (0.10)

9. Secondary Outcome

Title	Hb at Week 13
Time Frame	Week 13

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	149
Mean (Standard Error) [g/dL]	11.56 (0.10)	11.05 (0.10)

10. Secondary Outcome

Title	Hb at Week 15
Time Frame	Week 15

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	150
Mean (Standard Error) [g/dL]	11.42 (0.11)	11.25 (0.09)

11. Secondary Outcome

Title	Hb at Week 17
Time Frame	Week 17

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	138	150
Mean (Standard Error) [g/dL]	11.66 (0.10)	11.12 (0.09)

12. Secondary Outcome

Title	Hb at Week 19
Time Frame	Week 19

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	148
Mean (Standard Error) [g/dL]	11.50 (0.12)	11.20 (0.09)

13. Secondary Outcome

Title	Hb at Week 21
Time Frame	Week 21

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	137	146
Mean (Standard Error) [g/dL]	11.53 (0.10)	11.09 (0.08)

14. Secondary Outcome

Title	Hb at Week 23
Time Frame	Week 23

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	138	148
Mean (Standard Error) [g/dL]	11.36 (0.09)	11.08 (0.09)

15. Secondary Outcome

Title	Hb at Week 25
Time Frame	Week 25

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	151
Mean (Standard Error) [g/dL]	11.34 (0.10)	10.85 (0.09)

16. Secondary Outcome

Title	Hb at Week 27
Time Frame	Week 27

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	138	150
Mean (Standard Error) [g/dL]	11.22 (0.09)	11.07 (0.09)

17. Secondary Outcome

Title	Hb at Week 29
Time Frame	Week 29

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	137	151
Mean (Standard Error) [g/dL]	11.35 (0.10)	10.90 (0.09)

18. Secondary Outcome

Title	Hb at Week 31
Time Frame	Week 31

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	152
Mean (Standard Error) [g/dL]	11.31 (0.09)	11.28 (0.09)

19. Secondary Outcome

Title	Hb at Week 33
Time Frame	Week 33

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	136	149
Mean (Standard Error) [g/dL]	11.38 (0.10)	11.15 (0.10)

20. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 1
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	154
Geometric Mean (95% Confidence Interval) [µg/wk]	27.65 (0.10)	27.06 (0.10)

21. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 3
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 3

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	154
Geometric Mean (95% Confidence Interval) [µg/wk]	25.80 (0.10)	27.06 (0.10)

22. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 5
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 5

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	153
Geometric Mean (95% Confidence Interval) [µg/wk]	24.40 (0.10)	24.52 (0.10)

23. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 7
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 7

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	153
Geometric Mean (95% Confidence Interval) [µg/wk]	23.42 (0.10)	24.52 (0.10)

24. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 9
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 9

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	154
Geometric Mean (95% Confidence Interval) [µg/wk]	20.01 (0.10)	20.59 (0.10)

25. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 11
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 11

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	154
Geometric Mean (95% Confidence Interval) [µg/wk]	18.99 (0.10)	20.50 (0.10)

26. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 13
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 13

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	151
Geometric Mean (95% Confidence Interval) [µg/wk]	14.67 (0.10)	19.52 (0.10)

27. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 15
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 15

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	153
Geometric Mean (95% Confidence Interval) [µg/wk]	14.19 (0.10)	19.15 (0.10)

28. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 17
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 17

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	153
Geometric Mean (95% Confidence Interval) [µg/wk]	12.71 (0.10)	19.94 (0.10)

29. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 19
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 19

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	153
Geometric Mean (95% Confidence Interval) [µg/wk]	14.52 (0.10)	19.94 (0.10)

30. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 21
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 21

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	150
Geometric Mean (95% Confidence Interval) [µg/wk]	15.42 (0.10)	21.59 (0.10)

31. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 23
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 23

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	154
Geometric Mean (95% Confidence Interval) [µg/wk]	14.73 (0.10)	19.98 (0.10)

32. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 25
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 25

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	153
Geometric Mean (95% Confidence Interval) [µg/wk]	14.55 (0.10)	20.70 (0.10)

33. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 27
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 27

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	154
Geometric Mean (95% Confidence Interval) [µg/wk]	16.07 (0.10)	20.79 (0.10)

34. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 29
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 29

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	137	151
Geometric Mean (95% Confidence Interval) [µg/wk]	15.06 (0.10)	20.57 (0.10)

35. Secondary Outcome

Title	Darbepoetin Alfa Dose at Week 31
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 31

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	153
Geometric Mean (95% Confidence Interval) [µg/wk]	14.48 (0.10)	19.39 (0.10)

36. Secondary Outcome

Title	Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Weeks 29-33

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	153
Geometric Mean (95% Confidence Interval) [µg/wk]	15.21 (0.10)	19.68 (0.10)

37. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 3

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	154
Geometric Mean (95% Confidence Interval) [ratio]	0.931 (0.10)	1.000 (0.10)

38. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 5

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	153
Geometric Mean (95% Confidence Interval) [ratio]	0.882 (0.10)	0.907 (0.10)

39. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 7

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	153
Geometric Mean (95% Confidence Interval) [ratio]	0.845 (0.10)	0.907 (0.10)

40. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 9

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	154
Geometric Mean (95% Confidence Interval) [ratio]	0.724 (0.10)	0.761 (0.10)

41. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 11

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	154
Geometric Mean (95% Confidence Interval) [ratio]	0.684 (0.10)	0.758 (0.10)

42. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 13

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	151
Geometric Mean (95% Confidence Interval) [ratio]	0.531 (0.10)	0.719 (0.10)

43. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 15

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	153
Geometric Mean (95% Confidence Interval) [ratio]	0.512 (0.10)	0.707 (0.10)

44. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 17

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	153
Geometric Mean (95% Confidence Interval) [ratio]	0.459 (0.10)	0.737 (0.10)

45. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 19

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	153
Geometric Mean (95% Confidence Interval) [ratio]	0.525 (0.10)	0.737 (0.10)

46. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 21

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	150
Geometric Mean (95% Confidence Interval) [ratio]	0.556 (0.10)	0.797 (0.10)

47. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 23

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	141	154
Geometric Mean (95% Confidence Interval) [ratio]	0.533 (0.10)	0.738 (0.10)

48. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 25

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	153
Geometric Mean (95% Confidence Interval) [ratio]	0.526 (0.10)	0.764 (0.10)

49. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 27

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	154
Geometric Mean (95% Confidence Interval) [ratio]	0.581 (0.10)	0.768 (0.10)

50. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 29

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	137	151
Geometric Mean (95% Confidence Interval) [ratio]	0.544 (0.10)	0.762 (0.10)

51. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Week 31

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	153
Geometric Mean (95% Confidence Interval) [ratio]	0.525 (0.10)	0.717 (0.10)

52. Secondary Outcome

Title	Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Weeks 1-33

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	139	151
Geometric Mean (95% Confidence Interval) [µg/wk]	25.95 (0.10)	29.65 (0.10)

53. Secondary Outcome

Title	Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Time Frame	Weeks 1-33

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	142	154
Median (Inter-Quartile Range) [Weeks]	5.0	5.0

54. Secondary Outcome

Title	Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
Description	Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame	Evaluation Period

Outcome Measure Data

Analysis Population Description

Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

Arm/Group Title	Darbepoetin Alfa Q2W	Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks	Darbepoetin alfa Intravenous Once Monthly
Measure Participants	140	153
Geometric Mean (95% Confidence Interval) [ratio]	0.550 (0.10)	0.728 (0.10)

Adverse Events

Time Frame	33 weeks
Adverse Event Reporting Description	The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product.
Arm/Group Title	Darbepoetin Alfa Q2W		Darbepoetin Alfa QM
Arm/Group Description	Darbepoetin alfa Intravenous Once Every 2 Weeks		Darbepoetin alfa Intravenous Once Monthly
All Cause Mortality
	Darbepoetin Alfa Q2W		Darbepoetin Alfa QM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Darbepoetin Alfa Q2W		Darbepoetin Alfa QM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/175 (29.7%)		54/180 (30%)
Blood and lymphatic system disorders
Anaemia	2/175 (1.1%)		5/180 (2.8%)
Lymphadenopathy	0/175 (0%)		1/180 (0.6%)
Cardiac disorders
Acute coronary syndrome	1/175 (0.6%)		0/180 (0%)
Acute myocardial infarction	2/175 (1.1%)		0/180 (0%)
Angina pectoris	1/175 (0.6%)		2/180 (1.1%)
Arrhythmia	0/175 (0%)		1/180 (0.6%)
Arrhythmia supraventricular	1/175 (0.6%)		0/180 (0%)
Atrial fibrillation	2/175 (1.1%)		0/180 (0%)
Atrial flutter	0/175 (0%)		1/180 (0.6%)
Atrioventricular block complete	1/175 (0.6%)		1/180 (0.6%)
Cardiac failure	6/175 (3.4%)		3/180 (1.7%)
Cardiac failure acute	0/175 (0%)		1/180 (0.6%)
Cardiac failure congestive	1/175 (0.6%)		1/180 (0.6%)
Coronary artery disease	0/175 (0%)		1/180 (0.6%)
Ischaemic cardiomyopathy	1/175 (0.6%)		0/180 (0%)
Myocardial ischaemia	2/175 (1.1%)		0/180 (0%)
Tachyarrhythmia	1/175 (0.6%)		0/180 (0%)
Ventricular tachycardia	0/175 (0%)		1/180 (0.6%)
Ear and labyrinth disorders
Vertigo	1/175 (0.6%)		0/180 (0%)
Eye disorders
Cataract	0/175 (0%)		1/180 (0.6%)
Retinal haemorrhage	0/175 (0%)		1/180 (0.6%)
Visual impairment	2/175 (1.1%)		0/180 (0%)
Gastrointestinal disorders
Abdominal pain	1/175 (0.6%)		0/180 (0%)
Acute abdomen	0/175 (0%)		1/180 (0.6%)
Alcoholic pancreatitis	0/175 (0%)		1/180 (0.6%)
Diaphragmatic hernia	1/175 (0.6%)		0/180 (0%)
Diarrhoea	0/175 (0%)		2/180 (1.1%)
Dyspepsia	0/175 (0%)		2/180 (1.1%)
Gastric ulcer haemorrhage	0/175 (0%)		1/180 (0.6%)
Ileus	0/175 (0%)		3/180 (1.7%)
Impaired gastric emptying	1/175 (0.6%)		0/180 (0%)
Intestinal ischaemia	0/175 (0%)		1/180 (0.6%)
Melaena	1/175 (0.6%)		0/180 (0%)
General disorders
Asthenia	0/175 (0%)		1/180 (0.6%)
Chest pain	1/175 (0.6%)		1/180 (0.6%)
Generalised oedema	1/175 (0.6%)		0/180 (0%)
Inflammation	1/175 (0.6%)		0/180 (0%)
Oedema peripheral	2/175 (1.1%)		1/180 (0.6%)
Spinal pain	0/175 (0%)		1/180 (0.6%)
Hepatobiliary disorders
Biliary colic	1/175 (0.6%)		0/180 (0%)
Cholecystitis	1/175 (0.6%)		0/180 (0%)
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis	0/175 (0%)		1/180 (0.6%)
Infections and infestations
Abdominal abscess	1/175 (0.6%)		0/180 (0%)
Appendicitis	0/175 (0%)		1/180 (0.6%)
Bronchitis	1/175 (0.6%)		1/180 (0.6%)
Bronchopneumonia	0/175 (0%)		1/180 (0.6%)
Erysipelas	0/175 (0%)		2/180 (1.1%)
Gangrene	0/175 (0%)		1/180 (0.6%)
Gastroenteritis	0/175 (0%)		1/180 (0.6%)
Gastroenteritis viral	1/175 (0.6%)		0/180 (0%)
Infection	0/175 (0%)		1/180 (0.6%)
Lobar pneumonia	1/175 (0.6%)		0/180 (0%)
Parainfluenzae virus infection	0/175 (0%)		1/180 (0.6%)
Peritonitis	1/175 (0.6%)		0/180 (0%)
Pneumonia	3/175 (1.7%)		1/180 (0.6%)
Pyelonephritis chronic	1/175 (0.6%)		0/180 (0%)
Sepsis	1/175 (0.6%)		0/180 (0%)
Urinary tract infection	1/175 (0.6%)		2/180 (1.1%)
Injury, poisoning and procedural complications
Ankle fracture	0/175 (0%)		1/180 (0.6%)
Concussion	1/175 (0.6%)		0/180 (0%)
Fall	0/175 (0%)		1/180 (0.6%)
Femoral neck fracture	1/175 (0.6%)		0/180 (0%)
Femur fracture	1/175 (0.6%)		1/180 (0.6%)
Pelvic fracture	2/175 (1.1%)		0/180 (0%)
Post procedural complication	0/175 (0%)		2/180 (1.1%)
Radius fracture	1/175 (0.6%)		0/180 (0%)
Skull fractured base	1/175 (0.6%)		0/180 (0%)
Wrist fracture	1/175 (0.6%)		0/180 (0%)
Investigations
Blood glucose increased	0/175 (0%)		1/180 (0.6%)
Blood potassium increased	1/175 (0.6%)		0/180 (0%)
General physical condition abnormal	1/175 (0.6%)		0/180 (0%)
International normalised ratio increased	1/175 (0.6%)		0/180 (0%)
Metabolism and nutrition disorders
Dehydration	0/175 (0%)		1/180 (0.6%)
Diabetes mellitus	3/175 (1.7%)		1/180 (0.6%)
Diabetic ketoacidosis	0/175 (0%)		1/180 (0.6%)
Electrolyte imbalance	0/175 (0%)		1/180 (0.6%)
Fluid overload	0/175 (0%)		2/180 (1.1%)
Hyperkalaemia	0/175 (0%)		2/180 (1.1%)
Hypocalcaemia	0/175 (0%)		1/180 (0.6%)
Hypoglycaemia	0/175 (0%)		2/180 (1.1%)
Type 2 diabetes mellitus	1/175 (0.6%)		0/180 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/175 (0%)		1/180 (0.6%)
Osteoarthritis	1/175 (0.6%)		1/180 (0.6%)
Rhabdomyolysis	1/175 (0.6%)		0/180 (0%)
Spinal osteoarthritis	1/175 (0.6%)		0/180 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/175 (0.6%)		0/180 (0%)
Neoplasm malignant	1/175 (0.6%)		0/180 (0%)
Oesophageal carcinoma	0/175 (0%)		1/180 (0.6%)
Nervous system disorders
Carotid artery stenosis	1/175 (0.6%)		0/180 (0%)
Cerebral ischaemia	0/175 (0%)		1/180 (0.6%)
Cerebrovascular accident	0/175 (0%)		1/180 (0.6%)
Convulsion	1/175 (0.6%)		1/180 (0.6%)
Hemiparesis	1/175 (0.6%)		0/180 (0%)
Hypoaesthesia	1/175 (0.6%)		0/180 (0%)
Ischaemic stroke	0/175 (0%)		1/180 (0.6%)
Loss of consciousness	0/175 (0%)		2/180 (1.1%)
Syncope	0/175 (0%)		2/180 (1.1%)
Transient ischaemic attack	1/175 (0.6%)		0/180 (0%)
Vascular encephalopathy	1/175 (0.6%)		0/180 (0%)
Psychiatric disorders
Depression	1/175 (0.6%)		0/180 (0%)
Renal and urinary disorders
Azotaemia	1/175 (0.6%)		0/180 (0%)
Diabetic nephropathy	1/175 (0.6%)		1/180 (0.6%)
Nephropathy	1/175 (0.6%)		1/180 (0.6%)
Renal failure	4/175 (2.3%)		0/180 (0%)
Renal failure acute	0/175 (0%)		4/180 (2.2%)
Renal failure chronic	7/175 (4%)		4/180 (2.2%)
Reproductive system and breast disorders
Epididymitis	1/175 (0.6%)		0/180 (0%)
Oedema genital	1/175 (0.6%)		0/180 (0%)
Scrotal swelling	0/175 (0%)		1/180 (0.6%)
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic	0/175 (0%)		1/180 (0.6%)
Dyspnoea	2/175 (1.1%)		2/180 (1.1%)
Epistaxis	0/175 (0%)		1/180 (0.6%)
Pleural effusion	0/175 (0%)		1/180 (0.6%)
Pneumonia aspiration	0/175 (0%)		1/180 (0.6%)
Pulmonary oedema	1/175 (0.6%)		2/180 (1.1%)
Skin and subcutaneous tissue disorders
Dry gangrene	1/175 (0.6%)		0/180 (0%)
Erythema	0/175 (0%)		1/180 (0.6%)
Vascular disorders
Aortic aneurysm	0/175 (0%)		1/180 (0.6%)
Circulatory collapse	0/175 (0%)		1/180 (0.6%)
Extremity necrosis	1/175 (0.6%)		0/180 (0%)
Haematoma	1/175 (0.6%)		0/180 (0%)
Hypertension	3/175 (1.7%)		2/180 (1.1%)
Hypertensive crisis	0/175 (0%)		1/180 (0.6%)
Orthostatic hypotension	0/175 (0%)		1/180 (0.6%)
Peripheral ischaemia	0/175 (0%)		1/180 (0.6%)
Other (Not Including Serious) Adverse Events
	Darbepoetin Alfa Q2W		Darbepoetin Alfa QM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/175 (38.9%)		63/180 (35%)
Gastrointestinal disorders
Diarrhoea	10/175 (5.7%)		7/180 (3.9%)
General disorders
Asthenia	10/175 (5.7%)		5/180 (2.8%)
Oedema peripheral	17/175 (9.7%)		14/180 (7.8%)
Infections and infestations
Urinary tract infection	8/175 (4.6%)		10/180 (5.6%)
Metabolism and nutrition disorders
Hyperkalaemia	7/175 (4%)		12/180 (6.7%)
Vascular disorders
Hypertension	36/175 (20.6%)		30/180 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.