Clinical Trial: Study Evaluating Darbepoetin Alfa in Subjects with Chronic Kidney Disease (CKD) Receiving Dialysis

This study is no longer recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

Purpose

The purpose of this study is to evaluate the efficacy of Darbepoetin Alfa given once monthly to treat anemia in dialysis patients who were previously treated with Darbepoetin Alfa every other week.

Condition Treatment or Intervention Phase
Kidney Diseases
Chronic Disease
 Drug: Darbepoetin Alfa
Phase III

MedlinePlus related topics:  Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Single Group Assignment

Official Title: A Multicenter, Single-arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing in Subjects with Chronic Kidney Disease (CKD) Receiving Dialysis

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Diagnosis of chronic kidney disease (CKD) and receiving dialysis for > 3 months before enrollment
  • Clinically stable, in the judgment of the investigator
  • Mean Hb > 11.0 g/dL (110 g/L) to < 13.0 g/dL (130 g/L) (mean of 2 values drawn at least 3 days apart during the screening period)
  • Transferrin saturation (Tsat) > 19.5%
  • Serum vitamin B12 and folate levels above the lower limit of the normal range
  • Receiving stable intravenous (IV) or subcutaneous (SC) doses of Aranesp® (darbepoetin alfa) every 2 weeks (Q2W). A stable dose is defined as < 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period.

Exclusion Criteria:

  • Scheduled to receive a kidney transplant
  • Diastolic blood pressure > 110 mm Hg or systolic BP > 180 mm Hg during screening
  • Acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack within 12 weeks before enrollment
  • Parathyroid hormone (PTH) level > 150 pg/mL (158.0 pmol/L)
  • 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
  • Grand mal seizure within 6 months before enrollment

Location Information


Canada, Quebec
      Charles Le Moyne Hospital, Greenfield Park,  Quebec,  Canada

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers:  20040202
Record last reviewed:  February 2005
Last Updated:  February 4, 2005
Record first received:  November 17, 2004
ClinicalTrials.gov Identifier:  NCT00096915
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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