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

This study has been terminated.
(This study was stopped due to slow enrollment)
Sponsor:
Information provided by:
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00495365
First received: June 29, 2007
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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).


Condition Intervention Phase
Anemia
Chronic Renal Insufficiency
Drug: Epoetin alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Dose Conversion From Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa in Patients With the Anemia of Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Ortho Biotech Products, L.P.:

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

Enrollment: 8
Study Start Date: June 2003
Study Completion Date: September 2003
Detailed Description:

This was a prospective, multicenter study in subjects with chronic kidney disease. The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy.

The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24 week study period. Clinical safety was assessed for the occurrence and severity of adverse events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U epoetin alfa SC every 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT00495365

Sponsors and Collaborators
Ortho Biotech Products, L.P.
Investigators
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00495365     History of Changes
Other Study ID Numbers: CR005104
Study First Received: June 29, 2007
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho Biotech Products, L.P.:
Anemia
low blood count
chronic kidney disease
chronic kidney failure
darbepoetin alfa
epoetin alfa
recombinant human erythropoietin

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Hematologic Diseases
Urologic Diseases
Epoetin alfa
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014