Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

This study has been 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.)
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00211120
First received: September 13, 2005
Last updated: May 17, 2011
Last verified: March 2010
  Purpose

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 Intervention Phase
Anemia
Drug: Epoetin Alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 1432
Study Start Date: March 2002
Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211120

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00211120     History of Changes
Other Study ID Numbers: CR004588
Study First Received: September 13, 2005
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

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:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014