Trial Outcomes & Findings for A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities. (NCT NCT00337935)

NCT ID: NCT00337935

Last Updated: 2013-05-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

157 participants

Primary outcome timeframe

Week 0 to Week 26

Results posted on

2013-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Overall Study STARTED	39	118
Overall Study COMPLETED	29	91
Overall Study NOT COMPLETED	10	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Overall Study Adverse Event	2	5
Overall Study Death	2	8
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	0	1
Overall Study Protocol Violation	4	3
Overall Study Withdrawal by Subject	1	7
Overall Study Other	0	1
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=39 Participants Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) n=118 Participants epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks	Total n=157 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants	114 Participants n=7 Participants	151 Participants n=5 Participants
Age Continuous	84.4 Years STANDARD_DEVIATION 10.9 • n=5 Participants	84.1 Years STANDARD_DEVIATION 9.2 • n=7 Participants	84.1 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	90 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	28 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 26

Population: Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.

Outcome measures

Outcome measures
Measure	Standard of Care n=39 Participants Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) n=114 Participants epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)	0.3 g/dL Standard Deviation 1.3	0.9 g/dL Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0 to Week 26

Population: Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.

Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL

Outcome measures

Outcome measures
Measure	Standard of Care n=39 Participants Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) n=114 Participants epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
The Number of Patients Achieved a Hemoglobin Response.	21 participants	97 participants

SECONDARY outcome

Timeframe: Week 0 to Week 26

Population: Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.

Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.

Outcome measures

Outcome measures
Measure	Standard of Care n=39 Participants Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) n=114 Participants epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Time to Hemoglobin Response	114 Days Interval 43.0 to Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.	41 Days Interval 29.0 to 43.0

Adverse Events

Standard of Care

Serious events: 14 serious events

Other events: 34 other events

Deaths: 0 deaths

PROCRIT (Epoetin Alfa)

Serious events: 39 serious events

Other events: 99 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Vice President, Medical Affairs

Centocor Ortho-Biotech LLC.

Phone: 800.457.6399

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Standard of Care n=39 participants at risk Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) n=118 participants at risk epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Psychiatric disorders Aggression	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Renal and urinary disorders Renal Failure	7.7% 3/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Head Injury	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Hip Fracture	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Pneumonia Pneumococcal	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Sepsis	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Staphylococcal Infection	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Staphylococcal Sepsis	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Urinary Tract Infection	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	3.4% 4/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Wound Infection Staphylococcal	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Femur Fracture	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Therapeutic Agent Toxicity	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Investigations Anticonvulsant Drug Level Decreased	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Investigations Haemoglobin Decreased	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Investigations International Normalised Ratio Increased	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Investigations Weight Decreased	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Failure To Thrive	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Hyperkalaemia	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Hypoglycaemia	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Recurrent	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Nervous system disorders Dementia	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Nervous system disorders Dementia Alzheimer's Type	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Nervous system disorders Hypoaesthesia	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Nervous system disorders Syncope	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Renal and urinary disorders Renal Failure Acute	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	4.2% 5/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Renal and urinary disorders Renal Failure Chronic	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Renal and urinary disorders Urethral Perforation	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	2.5% 3/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Vascular disorders Aortic Embolus	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Vascular disorders Hypotension	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Urosepsis	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.

Other adverse events
Measure	Standard of Care n=39 participants at risk Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).	PROCRIT (Epoetin Alfa) n=118 participants at risk epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
Eye disorders Conjunctivitis	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	3.4% 4/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Gastrointestinal disorders Abdominal Pain	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	2.5% 3/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Gastrointestinal disorders Constipation	10.3% 4/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.1% 6/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Gastrointestinal disorders Diarrhoea	15.4% 6/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	16.1% 19/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Gastrointestinal disorders Dysphagia	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.9% 7/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Gastrointestinal disorders Nausea	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	8.5% 10/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Gastrointestinal disorders Vomiting	20.5% 8/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	18.6% 22/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
General disorders Localised Oedema	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
General disorders Oedema Peripheral	12.8% 5/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	11.0% 13/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Bronchitis	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.1% 6/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Upper Respiratory Tract Infection	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	16.9% 20/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Infections and infestations Urinary Tract Infection	23.1% 9/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	17.8% 21/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Contusion	15.4% 6/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	14.4% 17/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Excoriation	10.3% 4/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	6.8% 8/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Open Wound	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	4.2% 5/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Injury, poisoning and procedural complications Skin Laceration	15.4% 6/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	20.3% 24/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Dehydration	10.3% 4/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.1% 6/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 3/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	2.5% 3/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Hyperkalaemia	12.8% 5/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Hypoglycaemia	7.7% 3/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	7.6% 9/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Metabolism and nutrition disorders Hypokalaemia	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	9.3% 11/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Musculoskeletal and connective tissue disorders Back Pain	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Musculoskeletal and connective tissue disorders Muscular Weakness	7.7% 3/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	1.7% 2/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Musculoskeletal and connective tissue disorders Pain In Extremity	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	10.2% 12/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Nervous system disorders Lethargy	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	4.2% 5/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Psychiatric disorders Insomnia	7.7% 3/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	2.5% 3/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	9.3% 11/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.9% 7/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	2.5% 3/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	2.6% 1/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	6.8% 8/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Blister	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.9% 7/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Decubitus Ulcer	7.7% 3/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	4.2% 5/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Erythema	10.3% 4/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	4.2% 5/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Hyperkeratosis	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	7.6% 9/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Rash	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	9.3% 11/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Scab	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.85% 1/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Skin and subcutaneous tissue disorders Skin Irritation	5.1% 2/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	0.00% 0/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.
Vascular disorders Hypertension	0.00% 0/39 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.	5.9% 7/118 • 26 weeks or early withdraw Any ongoing adverse events were followed up to 30 days and serious adverse events until resolution. Serious adverse events were to be reported throughout the study including those serious adverse events spontaneously reported within 30 days after the patient completed the study.