Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00121602
First received: July 18, 2005
Last updated: February 21, 2008
Last verified: February 2008
  Purpose

The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with chronic kidney disease (CKD) receiving hemodialysis.


Condition Intervention Phase
Anemia
Kidney Disease
Drug: Darbepoetin Alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change in Hb level between the screening/baseline period and the evaluation period [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
  • The ratio of weekly dosing requirements between baseline and the evaluation period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Hb over time [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects maintaining mean Hb within target range during evaluation period [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Average darbepoetin alfa dose over evaluation period [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline dose over time [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]

Enrollment: 446
Study Start Date: March 2005
Study Completion Date: October 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roller bottle Drug: Darbepoetin Alfa
Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment. Frequency either once a week or once every two weeks, frequency may not change for duration of study. Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study. Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.
Experimental: Serum free Drug: Darbepoetin Alfa
Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment. Frequency either once a week or once every two weeks, frequency may not change for duration of study. Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study. Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.

  Eligibility

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

Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before enrollment - No prior exposure to EPREX® or NeoRecorman® - Baseline hemoglobin (Hb) between 10 and 13 g/dL - On stable weekly or once every other week intravenous (IV) or subcutaneous (SC) darbepoetin therapy for at least 6 weeks prior to screening (stable is defined as less than 25% change in weekly dose and no change in frequency) - Adequate iron stores (serum ferritin equal to or greater than 100 mg/L) - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria: - Scheduled to receive a kidney transplant - Uncontrolled hypertension, defined as a pre-dialysis systolic blood pressure (BP) greater than 180 and/or diastolic BP of greater than 110 - Acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment - Parathyroid hormone (PTH) level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women. All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Subject has known sensitivity to any of the products to be administered during dosing.

  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: NCT00121602

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00121602     History of Changes
Other Study ID Numbers: 20040104
Study First Received: July 18, 2005
Last Updated: February 21, 2008
Health Authority: Austria: Competant Authority
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement
Canada: Health Canada
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: CCPPRB Central Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Hemodialysis
Darbepoetin Alfa
Clinical Trials
Nephrology
Amgen
Chronic Kidney Disease (CKD)

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

ClinicalTrials.gov processed this record on September 30, 2014