Effects of Early Correction of Anemia in Patients With Chronic Renal Insufficiency

May 16, 2011 updated by: Janssen Cilag S.A.S.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Rate of progression of chronic renal failure over 36 months as measured by at least 2 glomerular filtration rate assessments.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Need for renal replacement therapy; quality of life; blood pressure control; hospital admissions; mortality; cardiovascular events; nutritional status.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Cilag S.A.S.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag S.A.S. Clinical Trial, Janssen Cilag S.A.S.

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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2001

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR003181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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