A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2003-05-31

Brief Summary

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The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.

Detailed Description

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Cardiovascular disease is very common among patients with end-stage renal disease. This study is a long-term, double-blind, parallel-group, multicenter study to determine the efficacy and safety of administering epoetin alfa to treat anemia (patients in Group 1) or partially treat anemia (patients in Group 2) in order to reduce the risk of heart failure in chronic renal failure patients on early dialysis and to improve their quality of life. Efficacy of epoetin alfa will be determined by comparing between Group 1 and Group 2 the heart structure (changes in left ventricle volume and mass viewed on echocardiograms), development of heart failure, correlation between changes in heart structure and hemoglobin level, a 6-minute walking test, and by 2 quality of life measures-a quality of life questionnaire and a fatigue questionnaire. Safety data associated with elevation of hemoglobin will be collected and monitored throughout the study: hemoglobin-related adverse events include thrombovascular events, seizures, and hypertension. Development of antibodies to erythropoetin over long-term treatment also will be assessed by serum samples gathered over the course of the study. The hypothesis of this study is that earlier and longer-term anemia intervention in patients without symptomatic heart disease or heart architecture distortions may conserve heart function and improve their quality of life, and that the intervention will be well tolerated by the patients. Patients not on epoetin alfa at start: epoetin alfa (50 IU/kg), 3 times per week with increases every 4 weeks at either 25 IU/kg or up to 25% of previous dose to reach target hemoglobin (Hb), then dose maintained. Patients on or switched to epoetin alfa at start are titrated to maintain target Hb.

Conditions

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Kidney Failure, Chronic Anemia

Keywords

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Kidney failure, Chronic End-stage renal disease Kidney failure Anemia Dialysis Epoetin Erythropoetin Epoetin alfa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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epoetin alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* On hemodialysis for 3 to 18 months and expected to remain on hemodialysis for at least two more years and with a life expectancy of a year or more
* Kidney transplant patients, whose transplant has failed, and now have been on hemodialysis for 3-18 months, may be eligible for the study, if they are not receiving excessive immunosuppression (e.g., \<=10 mg of steroids/day allowed)
* Pre-dialysis hemoglobin 8-12 g/dL, inclusive, within the previous month (single reading is sufficient)
* Stable hemodialysis vascular access, within the previous 3 months
* No heart disease or asymptomatic heart disease without enlarged heart

Exclusion Criteria

* Heart diseases for which surgical intervention occurred during the previous two years or which may require intervention within the next year
* Patients with medical conditions likely to affect the response to epoetin
* Predialysis sitting diastolic blood pressure \>= 100 mmHg on average for the previous month
* Folate, Vitamin B12, or transferrin deficiency
* History of seizure within 1 year
* Transfusion within 30 days prior to study entry.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

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Parfrey PS, Foley RN, Wittreich BH, Sullivan DJ, Zagari MJ, Frei D. Double-blind comparison of full and partial anemia correction in incident hemodialysis patients without symptomatic heart disease. J Am Soc Nephrol. 2005 Jul;16(7):2180-9. doi: 10.1681/ASN.2004121039. Epub 2005 May 18.

Reference Type RESULT

PMID: 15901766 (View on PubMed)

Williams CE, Curtis BM, Randell EW, Foley RN, Parfrey PS. Cardiac biomarkers and health-related quality of life in new hemodialysis patients without symptomatic cardiac disease. Can J Kidney Health Dis. 2014 Jul 15;1:16. doi: 10.1186/2054-3581-1-16. eCollection 2014.

Reference Type DERIVED

PMID: 26038709 (View on PubMed)

Other Identifiers

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CR004420

Identifier Type: -

Identifier Source: org_study_id