A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00442702
• Collaborator: (none)
• Enrollment: 228
• Locations: 91
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Drug: Mircera; Drug: Darbepoetin alfa	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mircera Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Drug: Mircera; Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.; Other Names: RO0503821 Methoxy polyethylene glycol-epoetin beta
Active Comparator: Darbepoetin alfa Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).	Drug: Darbepoetin alfa; As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.; Other Names: Aranesp®

Outcome Measures

Primary Outcome Measures

1. Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period [Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).]

   A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.

Secondary Outcome Measures

1. Change in Hemoglobin Concentration From Baseline Over Time [From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.]

2. Number of Participants With Red Blood Cell (RBC) Transfusions [From randomization to Month 9]

   Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.

3. Participants With Adverse Events [Randomization to Month 10 (final visit)]

   Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic kidney disease, not requiring dialysis;

• receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

• overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;

• transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;

• active malignant disease;

• previous treatment with Mircera.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Granada Hills	California	United States	91344
2		Lauderdale Lakes	Florida	United States	33313
3		Augusta	Georgia	United States	30309
4		Mineola	New York	United States	11501
5		Orchard Park	New York	United States	14127
6		Raleigh	North Carolina	United States	27609
7		Oregon City	Oregon	United States	97045
8		Providence	Rhode Island	United States	02903
9		Chattanooga	Tennessee	United States	37404
10		Salem	Virginia	United States	24153
11		Morgantown	West Virginia	United States	26506
12		Adelaide		Australia	SA 5000
13		Gosford		Australia	2250
14		Lismore		Australia	2480
15		Reservoir		Australia	3073
16		Richmond		Australia	3121
17		Aalst		Belgium	9300
18		Roeselare		Belgium	8800
19		Calgary	Alberta	Canada	T2N 2T9
20		St John's	Newfoundland and Labrador	Canada	A1B 3V6
21		Kingston	Ontario	Canada	K7L 3N6
22		Mississauga	Ontario	Canada	L5M 2V8
23		Toronto	Ontario	Canada	M5G 2C4
24		Toronto	Ontario	Canada	M9N 1N8
25		Montreal	Quebec	Canada	H2X 3J4
26		Marianske Lazne		Czech Republic	35301
27		Praha 2		Czech Republic	128 08
28		Praha 4		Czech Republic	14200
29		Praha		Czech Republic	14021
30		La Tronche		France	38700
31		Nantes		France	44035
32		Orleans		France	45100
33		Paris		France	75475
34		Rennes		France	35033
35		St Priest En Jarez		France	42277
36		Strasbourg		France	67091
37		Bad Hersfeld		Germany	36251
38		Bad König		Germany	64732
39		Berlin		Germany	13353
40		Bonn		Germany	53127
41		Coburg		Germany	96450
42		Demmin		Germany	17109
43		Dortmund		Germany	44263
44		München		Germany	80331
45		Baja		Hungary	6500
46		Budapest		Hungary	1071
47		Esztergom		Hungary	2500
48		Hodmezovasarhely		Hungary	6800
49		Kalocsa		Hungary	6300
50		Kecskemet		Hungary	6001
51		Szigetvar		Hungary	7390
52		VAC		Hungary	2600
53		Hadera		Israel	38100
54		Jerusalem		Israel	91031
55		Kfar Saba		Israel	44281
56		Nahariya		Israel	22100
57		Rehovot		Israel	76100
58		Brescia		Italy	25123
59		Chieti		Italy	66013
60		Ferrara		Italy	44100
61		Genova		Italy	16132
62		La Spezia		Italy	19124
63		Lecco		Italy	23900
64		Lodi		Italy	26900
65		Palermo		Italy	90127
66		Pavia		Italy	27100
67		Prato		Italy	50047
68		Roma		Italy	00186
69		S Fermo Della Battaglia		Italy	22020
70		Gdansk		Poland	80-211
71		Katowice		Poland	40-027
72		Lodz		Poland	90-153
73		Radom		Poland	20-610
74		Rzeszow		Poland	35-055
75		Sieradz		Poland	98-200
76		Szczecin		Poland	70-111
77		Warszawa		Poland	02-006
78		Barcelona		Spain	08025
79		Barcelona		Spain	08035
80		Barcelona		Spain	08036
81		Ciudad Real		Spain	13005
82		Hospitalet de Llobregat		Spain	08907
83		La Coruna		Spain	15006
84		Lerida		Spain	25198
85		Madrid		Spain	28007
86		Málaga		Spain	29010
87		Partida La Ceñuela. Torreviej		Spain	03186
88		Belfast		United Kingdom	BT9 7LJ
89		Birmingham		United Kingdom	B15 2TH
90		Bradford		United Kingdom	BD5 0NA
91		Exeter		United Kingdom	EX2 5DW

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00442702
• Other Study ID Numbers: BH20051
• First Posted: Mar 2, 2007
• Last Update Posted: Dec 19, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Darbepoetin alfa

Study Results

Participant Flow

Arm/Group Title	Mircera	Darbepoetin Alfa
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Period Title: Titration Period
STARTED	114	114
Safety Population	115	113
COMPLETED	102	111
NOT COMPLETED	12	3
Period Title: Titration Period
STARTED	102	111
COMPLETED	97	107
NOT COMPLETED	5	4

Baseline Characteristics

Arm/Group Title	Mircera	Darbepoetin Alfa	Total
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).	Total of all reporting groups
Overall Participants	114	114	228
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (11.03)	69.6 (14.02)	70.4 (12.62)
Sex: Female, Male (Count of Participants)
Female	66 57.9%	66 57.9%	132 57.9%
Male	48 42.1%	48 42.1%	96 42.1%

Outcome Measures

1. Primary Outcome

Title	Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
Description	A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
Time Frame	Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).

Outcome Measure Data

Analysis Population Description

Per Protocol population consisted of all randomized patients who had received at least one dose of trial medication and who have no major protocol violation. Data missing at the end of the evaluation period were handled using the last observation carried forward method (LOCF).

Arm/Group Title	Mircera	Darbepoetin Alfa
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Measure Participants	91	99
Baseline Hb	11.29 (0.382)	11.33 (0.397)
Change from baseline	0.15 (0.899)	-0.03 (0.693)

2. Secondary Outcome

Title	Change in Hemoglobin Concentration From Baseline Over Time
Time Frame	From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.

Outcome Measure Data

Analysis Population Description

Intent-to-treat population, including all randomized patients. "n" refers to the number of patients for whom data was available at each time point.

Arm/Group Title	Mircera	Darbepoetin Alfa
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Measure Participants	114	114
Baseline [n=114, 114]	11.27 (0.390)	11.31 (0.393)
Change at 0.5 Months [n=113, 114]	0.29 (0.737)	0.03 (0.490)
Change at 1 Month [n=114, 113]	0.34 (0.813)	0.06 (0.575)
Change at 1.5 Months [n=111, 113]	0.45 (0.866)	0.11 (0.599)
Change at 2 Months [n=112, 112]	0.27 (0.897)	0.02 (0.716)
Change at 2.5 Months [n=110, 112]	0.45 (0.924)	0.16 (0.673)
Change at 3 Months [n=111, 112]	0.23 (1.010)	0.10 (0.602)
Change at 3.5 Months [n=108, 108]	0.18 (1.095)	0.05 (0.675)
Change at 4 Months [n=109, 110]	0.05 (0.893)	0.00 (0.681)
Change at 4.5 Months [n=104, 108]	0.18 (0.940)	0.13 (0.699)
Change at 5 Months [n=108, 111]	-0.03 (0.897)	-0.07 (0.757)
Change at 5.5 Months [n=105, 110]	0.15 (0.922)	-0.03 (0.729)
Change at 6 Months [n=103, 111]	-0.05 (0.988)	-0.06 (0.820)
Change at 6.5 Months [n=100, 110]	0.06 (1.087)	0.04 (0.817)
Change at 7 Months [n=102, 111]	0.03 (1.008)	-0.00 (0.842)
Change at 7.5 Months [n=99, 110]	0.12 (1.166)	-0.00 (0.873)
Change at 8 Months [n=100, 108]	-0.04 (1.198)	-0.12 (0.905)
Change at 8.5 Months [n=97, 107]	0.14 (1.256)	0.02 (0.766)
Change at 9 Months [n=94, 101]	0.07 (1.045)	-0.06 (0.956)

3. Secondary Outcome

Title	Number of Participants With Red Blood Cell (RBC) Transfusions
Description	Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.
Time Frame	From randomization to Month 9

Outcome Measure Data

Analysis Population Description

Safety population included all randomized patients who received at least one dose of trial medication and a safety follow-up, according to the treatment received.

Arm/Group Title	Mircera	Darbepoetin Alfa
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Measure Participants	115	113
Entire Study	9 7.9%	3 2.6%
Titration Period	5 4.4%	1 0.9%
Evaluation Period	5 4.4%	2 1.8%

4. Secondary Outcome

Title	Participants With Adverse Events
Description	Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.
Time Frame	Randomization to Month 10 (final visit)

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Mircera	Darbepoetin Alfa
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.	Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Measure Participants	115	113
Any adverse event	102 89.5%	88 77.2%
Fatal Adverse event	4 3.5%	3 2.6%
Serious adverse event	41 36%	23 20.2%
Adverse event leading to withdrawal	3 2.6%	0 0%

Adverse Events

Time Frame	All adverse events that occurred from the first treatment dose were summarized. Adverse events were included up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.
Adverse Event Reporting Description	Safety population was used for analysis.
Arm/Group Title	Mircera		Darbepoetin Alfa
Arm/Group Description	Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.		Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
All Cause Mortality
	Mircera		Darbepoetin Alfa
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Mircera		Darbepoetin Alfa
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/115 (35.7%)		23/113 (20.4%)
Blood and lymphatic system disorders
NEPHROGENIC ANAEMIA	1/115 (0.9%)		0/113 (0%)
Cardiac disorders
CARDIAC FAILURE CONGESTIVE	2/115 (1.7%)		1/113 (0.9%)
ATRIAL FIBRILLATION	1/115 (0.9%)		1/113 (0.9%)
ACUTE MYOCARDIAL INFARCTION	1/115 (0.9%)		0/113 (0%)
AORTIC VALVE DISEASE MIXED	1/115 (0.9%)		0/113 (0%)
ARRHYTHMIA	1/115 (0.9%)		0/113 (0%)
ATRIAL FLUTTER	1/115 (0.9%)		0/113 (0%)
BRADYCARDIA	0/115 (0%)		1/113 (0.9%)
CARDIAC FAILURE	0/115 (0%)		1/113 (0.9%)
CARDIOGENIC SHOCK	1/115 (0.9%)		0/113 (0%)
CORONARY ARTERY DISEASE	1/115 (0.9%)		0/113 (0%)
MYOCARDIAL INFARCTION	1/115 (0.9%)		0/113 (0%)
MYOCARDIAL ISCHAEMIA	1/115 (0.9%)		0/113 (0%)
SICK SINUS SYNDROME	1/115 (0.9%)		0/113 (0%)
SILENT MYOCARDIAL INFARCTION	1/115 (0.9%)		0/113 (0%)
Ear and labyrinth disorders
VERTIGO	1/115 (0.9%)		2/113 (1.8%)
Eye disorders
CATARACT	0/115 (0%)		1/113 (0.9%)
Gastrointestinal disorders
PANCREATITIS ACUTE	2/115 (1.7%)		0/113 (0%)
COLITIS ISCHAEMIC	1/115 (0.9%)		0/113 (0%)
DIARRHOEA	1/115 (0.9%)		0/113 (0%)
GASTROINTESTINAL HAEMORRHAGE	0/115 (0%)		1/113 (0.9%)
HIATUS HERNIA	1/115 (0.9%)		0/113 (0%)
RECTAL POLYP	1/115 (0.9%)		0/113 (0%)
General disorders
NON-CARDIAC CHEST PAIN	0/115 (0%)		1/113 (0.9%)
OEDEMA PERIPHERAL	1/115 (0.9%)		0/113 (0%)
Hepatobiliary disorders
CHOLECYSTITIS	1/115 (0.9%)		0/113 (0%)
CHOLELITHIASIS	1/115 (0.9%)		0/113 (0%)
Infections and infestations
PNEUMONIA	2/115 (1.7%)		1/113 (0.9%)
RESPIRATORY TRACT INFECTION	2/115 (1.7%)		0/113 (0%)
BRONCHOPNEUMONIA	1/115 (0.9%)		0/113 (0%)
CORYNEBACTERIUM SEPSIS	0/115 (0%)		1/113 (0.9%)
GASTROENTERITIS	1/115 (0.9%)		0/113 (0%)
INFECTED SKIN ULCER	1/115 (0.9%)		0/113 (0%)
NEUROLOGICAL INFECTION	1/115 (0.9%)		0/113 (0%)
OSTEOMYELITIS	1/115 (0.9%)		0/113 (0%)
POST PROCEDURAL INFECTION	1/115 (0.9%)		0/113 (0%)
URINARY TRACT INFECTION	0/115 (0%)		1/113 (0.9%)
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE	2/115 (1.7%)		0/113 (0%)
FEMORAL NECK FRACTURE	1/115 (0.9%)		0/113 (0%)
PELVIC FRACTURE	1/115 (0.9%)		0/113 (0%)
Metabolism and nutrition disorders
FLUID OVERLOAD	1/115 (0.9%)		1/113 (0.9%)
HYPERKALAEMIA	0/115 (0%)		2/113 (1.8%)
DEHYDRATION	1/115 (0.9%)		0/113 (0%)
DIABETES MELLITUS INADEQUATE CONTROL	0/115 (0%)		1/113 (0.9%)
FLUID RETENTION	1/115 (0.9%)		0/113 (0%)
HYPOGLYCAEMIA	1/115 (0.9%)		0/113 (0%)
HYPONATRAEMIA	1/115 (0.9%)		0/113 (0%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/115 (0.9%)		0/113 (0%)
PATHOLOGICAL FRACTURE	1/115 (0.9%)		0/113 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANGIOSARCOMA	1/115 (0.9%)		0/113 (0%)
BASAL CELL CARCINOMA	0/115 (0%)		1/113 (0.9%)
COLON CANCER METASTATIC	1/115 (0.9%)		0/113 (0%)
Nervous system disorders
CEREBROVASCULAR ACCIDENT	1/115 (0.9%)		1/113 (0.9%)
ATAXIA	1/115 (0.9%)		0/113 (0%)
HEADACHE	1/115 (0.9%)		0/113 (0%)
NERVE ROOT COMPRESSION	0/115 (0%)		1/113 (0.9%)
PARTIAL SEIZURES	1/115 (0.9%)		0/113 (0%)
SCIATICA	1/115 (0.9%)		0/113 (0%)
TRANSIENT ISCHAEMIC ATTACK	0/115 (0%)		1/113 (0.9%)
VERTEBROBASILAR INSUFFICIENCY	0/115 (0%)		1/113 (0.9%)
Renal and urinary disorders
RENAL IMPAIRMENT	5/115 (4.3%)		0/113 (0%)
RENAL FAILURE CHRONIC	2/115 (1.7%)		1/113 (0.9%)
CALCULUS URETERIC	0/115 (0%)		1/113 (0.9%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA	0/115 (0%)		1/113 (0.9%)
Respiratory, thoracic and mediastinal disorders
ASTHMA	1/115 (0.9%)		0/113 (0%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0/115 (0%)		1/113 (0.9%)
Skin and subcutaneous tissue disorders
SKIN ULCER	2/115 (1.7%)		0/113 (0%)
Vascular disorders
ARTERIOSCLEROSIS	0/115 (0%)		1/113 (0.9%)
EXTREMITY NECROSIS	1/115 (0.9%)		0/113 (0%)
HYPERTENSION	0/115 (0%)		1/113 (0.9%)
Other (Not Including Serious) Adverse Events
	Mircera		Darbepoetin Alfa
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/115 (51.3%)		49/113 (43.4%)
Endocrine disorders
HYPERPARATHYROIDISM SECONDARY	8/115 (7%)		1/113 (0.9%)
Gastrointestinal disorders
DIARRHOEA	5/115 (4.3%)		8/113 (7.1%)
CONSTIPATION	6/115 (5.2%)		3/113 (2.7%)
General disorders
OEDEMA DUE TO RENAL DISEASE	6/115 (5.2%)		7/113 (6.2%)
Infections and infestations
NASOPHARYNGITIS	7/115 (6.1%)		13/113 (11.5%)
URINARY TRACT INFECTION	10/115 (8.7%)		4/113 (3.5%)
Musculoskeletal and connective tissue disorders
BACK PAIN	6/115 (5.2%)		3/113 (2.7%)
Renal and urinary disorders
RENAL IMPAIRMENT	13/115 (11.3%)		12/113 (10.6%)
Vascular disorders
HYPERTENSION	30/115 (26.1%)		20/113 (17.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.