AnemiaPhase 4NCT00312871
Effects of Early Correction of Anemia in Patients With Chronic Renal Insufficiency
A Phase 4 study testing Epoetin alfa in people with Anemia and Renal Failure, Chronic Renal Failure, run by Janssen Cilag S.A.S..
Trial summary
The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the kidneys). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia, Renal Failure, Chronic Renal Failure
- What is being tested?
- Epoetin alfa
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Feb 2001to Jun 2003
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of chronic renal failure, and at least a 6-month follow-up with at least 3 measurements of serum creatinine
- patients with a rate of decline in glomerular filtration rate (GFR--a measure of kidney function) below 0.6 mL/min/month
- patients with a hemoglobin level <13 g/dL for men and <12.5 g/dL for women without active blood loss or iron deficiency
- patients with a glomerular filtration rate (a measure of kidney function) between 25 and 60 mL/min/1.73m2)
- patients with blood pressure <=160/100 mm Hg (with or without antihypertensive therapy)
Who cannot join
- Patients with chronic renal failure (kidney dysfunction) associated with inherited polycystic kidney disease
- patients currently receiving treatment with epoetin for anemia secondary to chronic renal failure, and having a hemoglobin level >11 g/dL
- patients receiving epoetin but having a hemoglobin level below 11 g/dL will not be excluded
- patients with severe hypertension (blood pressure >= 180/110 mm Hg) within 3 months prior to study entry
- patients with a history of New York Heart Association (NYHA) class III or IV congestive heart failure within the preceding two years - NYHA class I and II congestive heart failure is accepted
- patients with a history of ischemic heart disease (deficient blood supply to the heart due to constricted or obstructed arteries)
- concurrent malignancy
- patients who have had a transfusion of red blood cells within 30 days prior to study
About this study
Official title: Effect of Early Correction of Anemia on the Progression of Chronic Renal Insufficiency (ECAP)
The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the kidneys). It also assesses the effect of hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement therapy, quality of life, blood pressure control, hospital admissions, mortality, cardiovascular events, nutritional status and safety.
Read the detailed description
Epoetin alfa can increase hemoglobin levels in chronic renal failure patients (patients with persistent kidney dysfunction) resulting in minimal transfusion requirements and improved kidney function capacity. This study is a randomized (patients randomly divided into groups), multicenter, open-label (study drug is known to the patients) clinical trial to assess the effect of normalization of hemoglobin (defined as a hemoglobin level of 13-14 g/dL in women and 14-15 g/dL in men) on the rate of progression of chronic renal failure (persistent kidney dysfunction). The study duration is 40 months. The study is in two phases (Phase A = stabilization, Phase B = maintenance) with two patient groups (Group 1, Group 2) per phase. In Phase A (lasting 4 months) for patients in Group 1, hemoglobin is progressively increased to a target level. Phase A can be extended up to 6 months for Group 1 patients in whom the target hemoglobin (13-14 g/dL in women, 14-15 g/dL in men) is not reached. Patients in Group 2, hemoglobin is progressively increased up to 12 g/dL with epoetin alfa if it drops below 11 g/dL. For all patients in Phase A, Iron and vitamin deficiencies will also be corrected, and factors known to affect progression of renal failure (kidney dysfunction) will be optimized. In Phase B (lasting 36 months), effectiveness of anemia correction by epoetin alfa will be compared against non-correction (continued anemia) with regard to changes in kidney function. During this phase, patients will be maintained at the higher (Group 1) or lower (Group 2) target hemoglobin level. Safety data (including cardiovascular events, seizures, and hypertension) will be collected and monitored throughout the study. The hypothesis of the study is that correction of anemia may slow down kidney deterioration and progression of kidney failure to end-stage kidney disease that is caused by anemia-induced hypoxia, a state of oxygen deficiency in the kidney. Another hypothesis of the study is that genetic mutations (changes in the genes) may play a role in the progression of chronic renal failure. For those patients wishing to participate in this aspect of the study, blood samples will be collected for genomic DNA analysis and the results will be compiled to determine which genes are generally associated in the study population with kidney deterioration. Patients will receive epoetin alfa injections (25 to 100 IU/kg) under the skin 1 time per week. Dosage may be increased by 25 IU/kg increments to reach or maintain target hemoglobin, then dose maintained for study duration, as long as hemoglobin stays within range.
- Conditions
- Anemia, Renal Failure, Chronic Renal Failure
- Being tested
- Epoetin alfa
- Keywords
- Chronic renal failure, Anemia, Renal replacement therapy, Epoetin, Epoetin alfa, erythropoietin, Chronic kidney failure, end-stage renal disease
- Medical subject headings
- Anemia, Kidney Failure, Chronic
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.
Rate of progression of chronic renal failure over 36 months as measured by at least 2 glomerular filtration rate assessments.
Secondary outcomes (1)
Need for renal replacement therapy; quality of life; blood pressure control; hospital admissions; mortality; cardiovascular events; nutritional status.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startFeb 2001
- Study completionJun 2003
Why it stopped: Study was stopped due to restrictions in labeling for the subcutaneous route of administration of EPREX.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag S.A.S. Clinical Trial, Study director, Janssen Cilag S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312871
- Sponsor's protocol ID
- CR003181
- Status last verified
- Apr 2010
- First submitted
- 7 Apr 2006
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Correction of Anemia on the Progression of Chronic Renal Insufficiency (ECAP)
- ClinicalTrials.gov ID
- NCT00312871
- Acronym / sponsor ID
- CR003181
- Conditions
- Anemia, Renal Failure, Chronic Renal Failure
- Keywords
- Chronic renal failure, Anemia, Renal replacement therapy, Epoetin, Epoetin alfa, erythropoietin, Chronic kidney failure, end-stage renal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to restrictions in labeling for the subcutaneous route of administration of EPREX.
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Janssen Cilag S.A.S.Industry (pharma, biotech, devices)
- Study start
- Feb 2001
- Study completion
- Jun 2003 (actual)
- First posted
- 11 Apr 2006 (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 the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the kidneys). It also assesses the effect of hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement therapy, quality of life, blood pressure control, hospital admissions, mortality, cardiovascular events, nutritional status and safety.
Detailed description
Epoetin alfa can increase hemoglobin levels in chronic renal failure patients (patients with persistent kidney dysfunction) resulting in minimal transfusion requirements and improved kidney function capacity. This study is a randomized (patients randomly divided into groups), multicenter, open-label (study drug is known to the patients) clinical trial to assess the effect of normalization of hemoglobin (defined as a hemoglobin level of 13-14 g/dL in women and 14-15 g/dL in men) on the rate of progression of chronic renal failure (persistent kidney dysfunction). The study duration is 40 months. The study is in two phases (Phase A = stabilization, Phase B = maintenance) with two patient groups (Group 1, Group 2) per phase. In Phase A (lasting 4 months) for patients in Group 1, hemoglobin is progressively increased to a target level. Phase A can be extended up to 6 months for Group 1 patients in whom the target hemoglobin (13-14 g/dL in women, 14-15 g/dL in men) is not reached. Patients in Group 2, hemoglobin is progressively increased up to 12 g/dL with epoetin alfa if it drops below 11 g/dL. For all patients in Phase A, Iron and vitamin deficiencies will also be corrected, and factors known to affect progression of renal failure (kidney dysfunction) will be optimized. In Phase B (lasting 36 months), effectiveness of anemia correction by epoetin alfa will be compared against non-correction (continued anemia) with regard to changes in kidney function. During this phase, patients will be maintained at the higher (Group 1) or lower (Group 2) target hemoglobin level. Safety data (including cardiovascular events, seizures, and hypertension) will be collected and monitored throughout the study. The hypothesis of the study is that correction of anemia may slow down kidney deterioration and progression of kidney failure to end-stage kidney disease that is caused by anemia-induced hypoxia, a state of oxygen deficiency in the kidney. Another hypothesis of the study is that genetic mutations (changes in the genes) may play a role in the progression of chronic renal failure. For those patients wishing to participate in this aspect of the study, blood samples will be collected for genomic DNA analysis and the results will be compiled to determine which genes are generally associated in the study population with kidney deterioration. Patients will receive epoetin alfa injections (25 to 100 IU/kg) under the skin 1 time per week. Dosage may be increased by 25 IU/kg increments to reach or maintain target hemoglobin, then dose maintained for study duration, as long as hemoglobin stays within range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a history of chronic renal failure, and at least a 6-month follow-up with at least 3 measurements of serum creatinine
- patients with a rate of decline in glomerular filtration rate (GFR--a measure of kidney function) below 0.6 mL/min/month
- patients with a hemoglobin level <13 g/dL for men and <12.5 g/dL for women without active blood loss or iron deficiency
- patients with a glomerular filtration rate (a measure of kidney function) between 25 and 60 mL/min/1.73m2)
- patients with blood pressure <=160/100 mm Hg (with or without antihypertensive therapy)
Key exclusion criteria (8 listed)
- Patients with chronic renal failure (kidney dysfunction) associated with inherited polycystic kidney disease
- patients currently receiving treatment with epoetin for anemia secondary to chronic renal failure, and having a hemoglobin level >11 g/dL
- patients receiving epoetin but having a hemoglobin level below 11 g/dL will not be excluded
- patients with severe hypertension (blood pressure >= 180/110 mm Hg) within 3 months prior to study entry
- patients with a history of New York Heart Association (NYHA) class III or IV congestive heart failure within the preceding two years - NYHA class I and II congestive heart failure is accepted
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
Rate of progression of chronic renal failure over 36 months as measured by at least 2 glomerular filtration rate assessments.
1 secondary outcome
Need for renal replacement therapy; quality of life; blood pressure control; hospital admissions; mortality; cardiovascular events; nutritional status.
Results and safety
The study was stopped early (reason given: Study was stopped due to restrictions in labeling for the subcutaneous route of administration of EPREX.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- Effect of Early Correction Of Anaemia on the Progression of Chronic Renal Insufficiency (ECAP)Link provided by the sponsor.
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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.
Janssen-Cilag S.A.S. Clinical Trial study director
Janssen Cilag S.A.S.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alfa in people with Anemia and Renal Failure, Chronic Renal Failure, run by Janssen Cilag S.A.S..
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 8 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: stopped early, as of the sponsor's last update on 17 May 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Study was stopped due to restrictions in labeling for the subcutaneous route of administration of EPREX.). Results are not available in the source record.
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?
Rate of progression of chronic renal failure over 36 months as measured by at least 2 glomerular filtration rate assessments.. 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 NCT00312871, which also lists 1 linked publication.
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 17 May 2011.