A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.

NCT00495365 | Terminated Phase 4

• 1 other identifier: CR005104
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL).

Conditions

Anemia; Chronic Renal Insufficiency

Keywords

Anemia; low blood count; chronic kidney disease; chronic kidney failure; darbepoetin alfa; epoetin alfa; recombinant human erythropoietin

Outcome Measures

Primary Outcomes (1)

• The primary objective was to evaluate the proportion of subjects who maintained hemoglobin levels within 10% of entry levels and/or a range of 11-13 g/dL for the 24-week duration of the study.

Secondary Outcomes (1)

• The secondary objective was to evaluate safety in subjects with chronic kidney disease throughout the study

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:

• Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 mg/dL for men
• glomerular filtration rate (GFR) within 15-60 mL/min
• Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin level of 12 (plus or minus 1 g/dL
• range 11-13 g/dL)
• Subjects receiving darbepoetin alfa on an every two, three, or four week dosing schedule
• female subjects with a reproductive potential must have a negative ruine pregnancy test within 7days of the first dose of study drug.

You may not qualify if:

• No uncontrolled high blood pressure as assessed by the primary physician
• No known hypersensitivity to mammalian cell-derived products
• No known hypersensitivity to human albumin
• Not receiving dialysis or scheduled to receive dialysis during the course of the study
• No severe congestive heart failure (New York Heart Association Class IV)
• No known severe stable or unstable coronary artery disease.

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

Related Links

• Evaluation of Dose Conversion from Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa (PROCRIT) in Patients with the Anemia of Chronic Kidney Disease

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, 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

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: June 1, 2003
• Study Completion: September 1, 2003
• Last Updated: May 19, 2011

Record last verified: 2010-04