- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261521
A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients
December 2, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Double-blind Study to Assess the Impact of Normalization of Hemoglobin Compared to Partial Correction of Hemoglobin With EPREX�/ERYPO� on Left Ventricular Structure in Early Hemodialysis Patients (RWJ-22512)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
596
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Percent change in left ventricular volume index (LVVI) at Week 96.
|
Secondary Outcome Measures
Outcome Measure |
---|
Percent change at Week 96 in left ventricular mass index (LVMI), development of new heart failure, correlation between change in left ventricular indices and average maintenance hemoglobin, 6-minute walking test, and quality of life.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2000
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
December 2, 2005
First Submitted That Met QC Criteria
December 2, 2005
First Posted (Estimate)
December 5, 2005
Study Record Updates
Last Update Posted (Estimate)
December 3, 2010
Last Update Submitted That Met QC Criteria
December 2, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004420
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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