Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

NCT00211120 | Terminated Phase 4 DMC

• 1 other identifier: CR004588
• Study Type: interventional
• Target: 1,432
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia

Keywords

Anemia; Low Blood Count; Chronic Kidney Failure; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

Epoetin Alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

Related Publications (2)

• Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98. doi: 10.1056/NEJMoa065485.

  PMID: 17108343 RESULT

• 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.

  PMID: 36791280 DERIVED

Related Links

• Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR))

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2002
• Study Completion: August 1, 2005
• Last Updated: May 18, 2011

Record last verified: 2010-03