Kidney Failure, ChronicPhase 3NCT00261521
A Study of the Safety and Efficacy of Long-term Correction of Anemia With Epoetin Alfa in Early Hemodialysis Patients
A Phase 3 study testing epoetin alfa in people with Kidney Failure, Chronic and Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Anemia
- What is being tested?
- epoetin alfa
- How many people
- 596 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to May 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Failure, Chronic, Anemia
- Being tested
- epoetin alfa
- Keywords
- Kidney failure, Chronic, End-stage renal disease, Kidney failure, Anemia, Dialysis, Epoetin, Erythropoetin, Epoetin alfa
- Medical subject headings
- Kidney Failure, Chronic, Anemia, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in left ventricular volume index (LVVI) at Week 96.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startFeb 2000
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261521
- Sponsor's protocol ID
- CR004420
- Status last verified
- Dec 2010
- First submitted
- 2 Dec 2005
- Last updated
- 3 Dec 2010
- Results posted
- No
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.
PubMed 15901766Williams 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.
PubMed 26038709
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00261521
- Acronym / sponsor ID
- CR004420
- Conditions
- Kidney Failure, Chronic, Anemia
- Keywords
- Kidney failure, Chronic, End-stage renal disease, Kidney failure, Anemia, Dialysis, Epoetin, Erythropoetin, Epoetin alfa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2000
- Study completion
- May 2003 (actual)
- First posted
- 5 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetin alfa | Drug | – |
Primary outcome
Percent change in left ventricular volume index (LVVI) at Week 96.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
- Results publication: PubMed 15901766Parfrey 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.
- Derived from this study: PubMed 26038709Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa in people with Kidney Failure, Chronic and Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in left ventricular volume index (LVVI) at Week 96.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00261521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.