A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02504294
• Collaborator: Hospira, now a wholly owned subsidiary of Pfizer (Industry)
• Enrollment: 432
• Locations: 45
• Arms: 2
• Actual Duration (Months): 12.1
• Patients Per Site: 9.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease (CKD)	Biological: Epoetin Hospira Arm; Other: Standard of Care Arm; Drug: IV Iron	Phase 3

Detailed Description

Primary Objective: To evaluate switching from Epogen to Epoetin Hospira for maintenance of hemoglobin levels in anemic chronic kidney disease (CKD) subjects on hemodialysis using a specified algorithm for the dosing of erythropoietin stimulating agents (ESA).

Secondary Objective: To evaluate switching from Epogen to Epoetin Hospira on the dosing of ESA in anemic CKD subjects on hemodialysis using a specified algorithm for the dosing of ESA.

Exploratory Objectives: To generate hypotheses regarding maintenance of hemoglobin levels, dosing of ESA, intravenous (IV) iron dosing requirements, transferrin saturation (TSAT) levels and ferritin levels associated with the switch from Epogen to Epoetin Hospira in anemic CKD subjects on hemodialysis using specified algorithms for the dosing of ESA and for the dosing of IV iron, that are standard of care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 432 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis
• Actual Study Start Date: Jul 13, 2015
• Actual Primary Completion Date: Jul 2, 2016
• Actual Study Completion Date: Jul 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Epoetin Hospira Epoetin Hospira Arm	Biological: Epoetin Hospira Arm; Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.; Drug: IV Iron; Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Other: Standard of Care Standard of care arm	Other: Standard of Care Arm; Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.; Drug: IV Iron; Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.

Outcome Measures

Primary Outcome Measures

1. Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) [Week 17 up to Week 24]

Secondary Outcome Measures

1. Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment [Baseline (8 Weeks prior to randomization), Week 17 up to Week 24]

Eligibility Criteria

Criteria

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

Inclusion Criteria

Subjects eligible to be entered into the study will meet all of the following criteria:

1. Adult female or male subjects; age ≥ 18 years.

2. End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days.

3. Diagnosed with anemia.

4. Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment of anemia using an Epogen version of an FMCNA dosing algorithm for ESA, and did not miss more than 3 prescribed doses of Epogen within 12 weeks prior to randomization.

5. Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, …) for anemia management.

6. Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care treatment for iron replacement.

Exclusion Criteria

Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:

1. Subjects unable to provide a signed and dated informed consent for this clinical research study.

2. As determined by the Investigator, female subjects of child bearing potential who do not agree to use a highly effective method of contraception.

3. Any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.

4. Female subjects who are known to be or found to be, pregnant or lactating.

5. Subjects that are not a candidate for ESA therapies per the label warnings listed in the package insert for Epogen and/or contraindications to Epoetin Hospira listed in the Investigators' Brochure; or have had a known positive test for anti-rhEPO antibodies.

6. Treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.

7. Diagnosed with any concurrent condition that could lead to greater-than-normal loss of blood, including but not limited to:

• Menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia, hemoglobinopathy

• Use of anticoagulation therapy, including warfarin with a target international normalized ratio (INR) of 2 or greater Anti-platelet therapy (e.g. aspirin or clopidogrel) is permitted, as is heparin given during hemodialysis. Low-dose warfarin is permitted and defined as the presence of at least two INR values less than or equal to 1.5 during the 120 days prior to enrollment and no values exceeding 1.5 at any time after 120 days prior to enrollment.

Subjects started on warfarin with a known INR goal of 2.0 or greater are to receive no further treatment with the study drugs, but follow up visits can continue.

Subjects on warfarin who meet criteria to enter the study are terminated if an INR > 2.0 is discovered or if no INR is available for 60 days.

1. History of transfusion of any blood product in the past 3 months, or 2 or more transfusions in the past 1 year; or donated or lost > 475 mL blood volume (including plasmapheresis) in the past 3 months.

2. Subjects currently receiving a long acting ESA, or who have received a long acting ESA in the 16 weeks prior to study randomization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Institute of Renal Research	Chula Vista	California	United States	91910
2	California Institute of Renal Research at Fresenius Medical Care	Poway	California	United States	92064
3	Fresenius Medical Care Rancho	Rancho Bernardo	California	United States	92127
4	California Institute of Renal Research at Fresenius Medical Care Kearny Mesa	San Diego	California	United States	92111
5	Fresenius Medical Care Paradise Valley	San Diego	California	United States	92139
6	Fresenius Medical Care	Tampa	Florida	United States	33609
7	Fresenius Medical Care	Tampa	Florida	United States	33610
8	Genesis Clinical Research, LLC	Tampa	Florida	United States	33614
9	Frenova Renal Research	Boise	Idaho	United States	83702
10	Fresenius Medical Care North America - Liberty Dialysis	Boise	Idaho	United States	83702
11	Frenova Renal Research	Caldwell	Idaho	United States	83605
12	Fresenius Medical Care North America - Liberty Dialysis	Caldwell	Idaho	United States	83605
13	Frenova Renal Research	Meridian	Idaho	United States	83642
14	Fresenius Medical Care North America - Liberty Dialysis	Meridian	Idaho	United States	83642
15	Frenova Renal Research	Nampa	Idaho	United States	83686
16	Fresenius Medical Care North America - Liberty Dialysis	Nampa	Idaho	United States	83686
17	Fresenius Medical Care-Kalamazoo East	Kalamazoo	Michigan	United States	49001
18	Paragon Health PC DBA Nephrology Center	Kalamazoo	Michigan	United States	49007
19	Fresenius Medical Care-Oshtemo	Kalamazoo	Michigan	United States	49009
20	Fresenius Medical Care, Biloxi Dialysis Unit	Biloxi	Mississippi	United States	39530
21	North Gulfport	Gulfport	Mississippi	United States	39501
22	South Mississippi Kidney Center	Gulfport	Mississippi	United States	39503
23	FMC Charlotte	Charlotte	North Carolina	United States	28204
24	Metrolina Nephrology Associates, PA	Charlotte	North Carolina	United States	28204
25	Briggs Avenue Dialysis Center	Durham	North Carolina	United States	27703
26	Durham Nephrology Associates	Durham	North Carolina	United States	27704
27	FMC Matthews	Matthews	North Carolina	United States	28105
28	Fresenius Medical Care- Lansdale Dialysis	Lansdale	Pennsylvania	United States	19446
29	Delaware Valley Nephrology and Hypertension Associates, PC	Philadelphia	Pennsylvania	United States	19118
30	Fresenius Medical Care	Warwick	Rhode Island	United States	02886
31	Fresenius Crossville Dialysis Unit	Crossville	Tennessee	United States	38555
32	Fresenius Medical Care-Franklin	Franklin	Tennessee	United States	37067
33	Knoxville Kidney Center, PLLC	Knoxville	Tennessee	United States	37923
34	Fresenius Dialysis West	Knoxville	Tennessee	United States	37934
35	Nephrology Associates, PC	Nashville	Tennessee	United States	37205
36	Fresenius Medical Care - Austin North 4478	Austin	Texas	United States	78758
37	Research Management Inc	Austin	Texas	United States	78758
38	Mission Bend Dialysis (FMC#3971)	Houston	Texas	United States	77083
39	Southwest Houston Research, Ltd.	Houston	Texas	United States	77099
40	Gamma Medical Research Inc	McAllen	Texas	United States	78503
41	Rosenberg Dialysis (FMC#1197)	Rosenberg	Texas	United States	77471
42	Fresenius Medical Care Weslaco	Weslaco	Texas	United States	78596
43	Fresenius Medical Care Carolina	Carolina		Puerto Rico	00983
44	Fresenius Medical Care	Humacao		Puerto Rico	00791
45	Fresenius Medical Care San Juan	San Juan		Puerto Rico	00917

Sponsors and Collaborators

• Pfizer
• Hospira, now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02504294
• Other Study ID Numbers: ZIN-EPO-1503; C3461008
• First Posted: Jul 21, 2015
• Last Update Posted: Jun 13, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Epoetin Alfa

Study Results

Participant Flow

Pre-assignment Detail	In this study, 432 participants were enrolled, however, only 418 participants were treated.

Arm/Group Title	Epoetin Hospira	Epogen
Arm/Group Description	Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.	Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
Period Title: Overall Study
STARTED	212	206
COMPLETED	156	158
NOT COMPLETED	56	48

Baseline Characteristics

Arm/Group Title	Epoetin Hospira	Epogen	Total
Arm/Group Description	Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.	Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.	Total of all reporting groups
Overall Participants	212	206	418
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.5 (13.96)	59.3 (14.23)	59.9 (14.09)
Sex: Female, Male (Count of Participants)
Female	82 38.7%	102 49.5%	184 44%
Male	130 61.3%	104 50.5%	234 56%

Outcome Measures

1. Primary Outcome

Title	Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)
Time Frame	Week 17 up to Week 24

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication after randomization into the study. Here, "Number of participants analyzed (N)" signifies those number of participants who were evaluable for this outcome measure.

Arm/Group Title	Epoetin Hospira	Epogen
Arm/Group Description	Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.	Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
Measure Participants	178	173
Number (95% Confidence Interval) [Percentage of Weeks]	61.9330	63.3305

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Epoetin Hospira, Epogen
	Comments	Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage
	Estimated Value	-1.3975
	Confidence Interval	(2-Sided) 95%; -7.6503 to 4.8553
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment
Time Frame	Baseline (8 Weeks prior to randomization), Week 17 up to Week 24

Outcome Measure Data

Analysis Population Description

FAS included all participants who received at least 1 dose of study medication after randomization in to the study. Here, "N" signifies number of participants who were evaluable for this outcome measure.

Arm/Group Title	Epoetin Hospira	Epogen
Arm/Group Description	Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.	Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
Measure Participants	180	174
Least Squares Mean (Standard Error) [Units per week]	-1861.8 (563.50)	-799.8 (573.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Epoetin Hospira, Epogen
	Comments	P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1874
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1062.0
	Confidence Interval	(2-Sided) 95%; -2643.2 to 519.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 803.95
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Arm/Group Title	Epoetin Hospira		Epogen
Arm/Group Description	Participants received intravenous (IV) injection of Epoetin Hospira as per the analogous version of Fresenius Medical Care North America (FMCNA) Erythropoietin Stimulating Agent (ESA) dosing algorithm Corporate Medical Advisory board (cMAB algorithm 1) along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.		Participants received their ongoing standard of care which included IV injection of Epogen, as per the current version of the FMCNA ESA dosing algorithm cMAB 5 along with IV iron as per the FMCNA standard of care. Drug was administered up to maximum 3 times per week up to Week 24. Participants were followed up to Week 26.
All Cause Mortality
	Epoetin Hospira		Epogen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Epoetin Hospira		Epogen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/212 (31.1%)		64/206 (31.1%)
Blood and lymphatic system disorders
Anaemia	1/212 (0.5%)		2/206 (1%)
Haemorrhagic anaemia	0/212 (0%)		1/206 (0.5%)
Cardiac disorders
Acute myocardial infarction	2/212 (0.9%)		2/206 (1%)
Angina pectoris	0/212 (0%)		1/206 (0.5%)
Angina unstable	1/212 (0.5%)		0/206 (0%)
Atrial fibrillation	1/212 (0.5%)		0/206 (0%)
Atrial flutter	1/212 (0.5%)		0/206 (0%)
Bradycardia	1/212 (0.5%)		0/206 (0%)
Cardiac arrest	2/212 (0.9%)		6/206 (2.9%)
Cardiac failure congestive	0/212 (0%)		3/206 (1.5%)
Cardio-respiratory arrest	0/212 (0%)		2/206 (1%)
Coronary artery disease	0/212 (0%)		2/206 (1%)
Diastolic dysfunction	0/212 (0%)		1/206 (0.5%)
Hypertensive heart disease	1/212 (0.5%)		0/206 (0%)
Myocardial infarction	1/212 (0.5%)		0/206 (0%)
Ventricular tachycardia	1/212 (0.5%)		0/206 (0%)
Endocrine disorders
Hyperparathyroidism secondary	1/212 (0.5%)		0/206 (0%)
Parathyroid disorder	0/212 (0%)		1/206 (0.5%)
Gastrointestinal disorders
Abdominal distension	1/212 (0.5%)		0/206 (0%)
Abdominal pain	1/212 (0.5%)		0/206 (0%)
Abdominal pain lower	0/212 (0%)		1/206 (0.5%)
Gastrointestinal haemorrhage	2/212 (0.9%)		1/206 (0.5%)
Impaired gastric emptying	0/212 (0%)		1/206 (0.5%)
Large intestine perforation	0/212 (0%)		1/206 (0.5%)
Lower gastrointestinal haemorrhage	0/212 (0%)		1/206 (0.5%)
Nausea	1/212 (0.5%)		2/206 (1%)
Upper gastrointestinal haemorrhage	1/212 (0.5%)		0/206 (0%)
Vomiting	1/212 (0.5%)		2/206 (1%)
General disorders
Asthenia	0/212 (0%)		1/206 (0.5%)
Catheter site haemorrhage	0/212 (0%)		1/206 (0.5%)
Chest discomfort	1/212 (0.5%)		0/206 (0%)
Chest pain	3/212 (1.4%)		1/206 (0.5%)
Condition aggravated	4/212 (1.9%)		3/206 (1.5%)
Death	2/212 (0.9%)		0/206 (0%)
Early satiety	1/212 (0.5%)		0/206 (0%)
Generalised oedema	0/212 (0%)		1/206 (0.5%)
Hernia	0/212 (0%)		1/206 (0.5%)
Impaired healing	0/212 (0%)		2/206 (1%)
Medical device site ulcer	0/212 (0%)		1/206 (0.5%)
Pain	1/212 (0.5%)		0/206 (0%)
Pyrexia	0/212 (0%)		1/206 (0.5%)
Systemic inflammatory response syndrome	0/212 (0%)		1/206 (0.5%)
Ulcer haemorrhage	0/212 (0%)		1/206 (0.5%)
Hepatobiliary disorders
Cholecystitis acute	1/212 (0.5%)		0/206 (0%)
Cholelithiasis	1/212 (0.5%)		0/206 (0%)
Infections and infestations
Bacteraemia	1/212 (0.5%)		0/206 (0%)
Cellulitis	0/212 (0%)		1/206 (0.5%)
Cellulitis of male external genital organ	0/130 (0%)		1/104 (1%)
Clostridium difficile colitis	1/212 (0.5%)		0/206 (0%)
Device related sepsis	1/212 (0.5%)		0/206 (0%)
Diverticulitis	0/212 (0%)		1/206 (0.5%)
Endocarditis	1/212 (0.5%)		0/206 (0%)
Escherichia bacteraemia	1/212 (0.5%)		0/206 (0%)
Gastroenteritis	2/212 (0.9%)		1/206 (0.5%)
Graft infection	1/212 (0.5%)		0/206 (0%)
Incision site infection	1/212 (0.5%)		0/206 (0%)
Infection	2/212 (0.9%)		0/206 (0%)
Osteomyelitis	0/212 (0%)		2/206 (1%)
Osteomyelitis chronic	1/212 (0.5%)		0/206 (0%)
Pneumonia	7/212 (3.3%)		1/206 (0.5%)
Pneumonia bacterial	1/212 (0.5%)		0/206 (0%)
Pyelonephritis	2/212 (0.9%)		0/206 (0%)
Pyuria	1/212 (0.5%)		0/206 (0%)
Respiratory syncytial virus infection	0/212 (0%)		1/206 (0.5%)
Sepsis	3/212 (1.4%)		1/206 (0.5%)
Septic shock	2/212 (0.9%)		1/206 (0.5%)
Subcutaneous abscess	0/212 (0%)		1/206 (0.5%)
Urinary tract infection	2/212 (0.9%)		2/206 (1%)
Wound infection	0/212 (0%)		1/206 (0.5%)
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage	1/212 (0.5%)		2/206 (1%)
Arteriovenous fistula thrombosis	1/212 (0.5%)		0/206 (0%)
Arteriovenous graft site haemorrhage	1/212 (0.5%)		1/206 (0.5%)
Arteriovenous graft thrombosis	1/212 (0.5%)		1/206 (0.5%)
Fall	0/212 (0%)		1/206 (0.5%)
Femur fracture	0/212 (0%)		1/206 (0.5%)
Intentional product misuse	1/212 (0.5%)		0/206 (0%)
Limb injury	0/212 (0%)		1/206 (0.5%)
Post procedural pulmonary embolism	0/212 (0%)		1/206 (0.5%)
Pubis fracture	0/212 (0%)		1/206 (0.5%)
Rib fracture	0/212 (0%)		1/206 (0.5%)
Tibia fracture	1/212 (0.5%)		1/206 (0.5%)
Vascular access complication	0/212 (0%)		2/206 (1%)
Vascular access malfunction	0/212 (0%)		1/206 (0.5%)
Vascular bypass dysfunction	1/212 (0.5%)		0/206 (0%)
Vascular pseudoaneurysm	1/212 (0.5%)		0/206 (0%)
Wound	1/212 (0.5%)		0/206 (0%)
Wound dehiscence	0/212 (0%)		1/206 (0.5%)
Investigations
Haemoglobin decreased	1/212 (0.5%)		0/206 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/212 (0%)		1/206 (0.5%)
Failure to thrive	1/212 (0.5%)		0/206 (0%)
Fluid overload	4/212 (1.9%)		3/206 (1.5%)
Hyperglycaemia	0/212 (0%)		1/206 (0.5%)
Hyperkalaemia	5/212 (2.4%)		1/206 (0.5%)
Hypoglycaemia	1/212 (0.5%)		1/206 (0.5%)
Hypovolaemia	0/212 (0%)		1/206 (0.5%)
Malnutrition	0/212 (0%)		1/206 (0.5%)
Musculoskeletal and connective tissue disorders
Muscular weakness	1/212 (0.5%)		0/206 (0%)
Pain in extremity	1/212 (0.5%)		0/206 (0%)
Systemic lupus erythematosus	0/212 (0%)		1/206 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV	1/212 (0.5%)		0/206 (0%)
Prostate cancer	1/130 (0.8%)		0/104 (0%)
Nervous system disorders
Cerebrovascular accident	2/212 (0.9%)		1/206 (0.5%)
Encephalopathy	1/212 (0.5%)		2/206 (1%)
Hemiparesis	0/212 (0%)		1/206 (0.5%)
Ischaemic stroke	0/212 (0%)		1/206 (0.5%)
Lethargy	0/212 (0%)		1/206 (0.5%)
Metabolic encephalopathy	2/212 (0.9%)		0/206 (0%)
Syncope	2/212 (0.9%)		0/206 (0%)
Transient ischaemic attack	0/212 (0%)		1/206 (0.5%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/82 (0%)		1/102 (1%)
Psychiatric disorders
Anxiety	1/212 (0.5%)		0/206 (0%)
Major depression	1/212 (0.5%)		0/206 (0%)
Renal and urinary disorders
Obstructive uropathy	1/212 (0.5%)		0/206 (0%)
Urethral haemorrhage	0/212 (0%)		1/206 (0.5%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/212 (0.5%)		1/206 (0.5%)
Acute respiratory failure	2/212 (0.9%)		2/206 (1%)
Asthma	0/212 (0%)		1/206 (0.5%)
Bronchial secretion retention	1/212 (0.5%)		0/206 (0%)
Choking	1/212 (0.5%)		0/206 (0%)
Chronic obstructive pulmonary disease	2/212 (0.9%)		0/206 (0%)
Dyspnoea	2/212 (0.9%)		0/206 (0%)
Hypoxia	0/212 (0%)		2/206 (1%)
Pleural effusion	0/212 (0%)		2/206 (1%)
Pulmonary oedema	2/212 (0.9%)		2/206 (1%)
Respiratory arrest	0/212 (0%)		1/206 (0.5%)
Respiratory failure	1/212 (0.5%)		1/206 (0.5%)
Tracheomalacia	1/212 (0.5%)		0/206 (0%)
Skin and subcutaneous tissue disorders
Purpura	1/212 (0.5%)		0/206 (0%)
Surgical and medical procedures
Renal transplant	1/212 (0.5%)		1/206 (0.5%)
Vascular disorders
Hypertension	0/212 (0%)		1/206 (0.5%)
Hypertensive crisis	1/212 (0.5%)		2/206 (1%)
Hypotension	0/212 (0%)		2/206 (1%)
Peripheral artery occlusion	0/212 (0%)		1/206 (0.5%)
Steal syndrome	0/212 (0%)		1/206 (0.5%)
Other (Not Including Serious) Adverse Events
	Epoetin Hospira		Epogen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/212 (4.7%)		21/206 (10.2%)
Gastrointestinal disorders
Nausea	3/212 (1.4%)		13/206 (6.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	7/212 (3.3%)		11/206 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.