Full Text View
Tabular View
No Study Results Posted
Related Studies
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. )
First Received: September 13, 2005   Last Updated: April 24, 2008   History of Changes
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00211120
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Estimated Enrollment: 1352
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 weeksprior to study entry
  Contacts and Locations
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 and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
Study ID Numbers: CR004588
Study First Received: September 13, 2005
Last Updated: April 24, 2008
ClinicalTrials.gov Identifier: NCT00211120     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Low Blood Count
Chronic Kidney Failure
Chronic Kidney Disease
Anemia

Study placed in the following topic categories:
Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics
Hematologic Diseases
Renal Insufficiency, Chronic
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents
Anemia
Kidney Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009