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Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

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ClinicalTrials.gov Identifier: NCT00211120
Recruitment Status : Terminated (Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin (Hb) arm and <5% chance that the study would show benefit for higher Hb.)
First Posted : September 21, 2005
Last Update Posted : May 18, 2011
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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Brief Summary:
The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin Alfa Phase 4

Detailed Description:

This is a prospective, open-label, randomized, multi-center study in patients with CKD. Patients who meet the selection criteria will be randomly assigned to one of two treatment arms: GROUP A: PROCRIT® (Epoetin alfa) therapy directed at maintaining the hemoglobin level as close to 13.5 g/dL as possible (may be slightly higher or lower) or GROUP B: PROCRIT® (Epoetin alfa) therapy directed at maintaining the hemoglobin level as close to 11.3 g/dL as possible (may be slightly higher or lower).

Patients will receive weekly doses of PROCRIT® (Epoetin alfa). Subsequent doses of PROCRIT® will be given weekly as needed with dose adjustments made to maintain the hemoglobin (Hb) as close to the target level as possible until the initiation of Renal Replacement Therapy (RRT) or 36 months, whichever comes first.

The purpose of this study is to compare the outcomes of patients with CKD randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity. Patients will receive a starting dose of PROCRIT® 10,000 Units (U) subcutaneously (SC) 1x / week. After 3 weekly doses, subsequent doses and dosing intervals of PROCRIT®, up to a maximum dose of 20,000 U for 36 months, will be adjusted based on an assessment of the two most recent hemoglobin values.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Study Start Date : March 2002
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)

Secondary Outcome Measures :
  1. All cause mortality; Myocardial infarction; Stroke; RRT;CHF, Cardiovascular and all cause hospitalizations, Change from baseline in hemoglobin, Quality of Life Scores (SF36, KDQ, LASA), transfusions

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Kidney Disease:Glomerular filtration rate (GFR) > 15 mL/min and > 50 mL/min as calculated by the central lab. HB<11 g/dL upon study enrollment. The GFR for assessment of patient eligibility will be determined using the formula derived from the Modification of Diet for Renal Disease (MDRD) Study.

Exclusion Criteria:

  • Pregnant or lactating women
  • Presence of uncontrolled hypertension
  • Known hypersensitivity to mammalian cell-derived products or human albumin
  • Active gastrointestinal bleeding
  • Iron overload defined as a transferrin saturation >70% or ferritin >1000 ng/mL
  • History of frequent blood transfusions in the past 6 months
  • Unstable angina or angina pectoris at rest
  • Severe chronic obstructive pulmonary disease requiring routine use of supplemental oxygen
  • Severe liver dysfunction that is defined by an international normalized ratio >2.0, not caused by an anticoagulant
  • Severe malnutrition
  • Active hematological disease (eg, sickle cell anemia, thalassemia)
  • Active malignancy (usually defined as malignancy requiring current chemotherapy or radiotherapy)
  • Patients with current seizure disorder or activity
  • Patients currently receiving RRT (patient can not be on dialysis or have had a kidney transplant)
  • Patients who have received Epoetin Alpha within 6 weeks prior to study entry
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211120


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Clinical Affairs, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Additional Information:

Publications of Results:

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ClinicalTrials.gov Identifier: NCT00211120    
Other Study ID Numbers: CR004588
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: March 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
Low Blood Count
Chronic Kidney Failure
Chronic Kidney Disease
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics