Clinical Trial: OPUS Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients with Chronic Kidney Disease

This study is currently recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

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 III

MedlinePlus related topics:  Anemia;   Kidney Diseases

Study Type: Interventional
Study Design: Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 

Study start: March 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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) Aranesp® 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 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 or myocardial infarction 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
  • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00121602

Amgen Call Center      866-572-6436    mit@amgen.com

New York
      Research Center, Olean,  New York,  United States; Recruiting

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers:  20040104
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00121602
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26

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