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Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096915
Recruitment Status : Completed
First Posted : November 18, 2004
Last Update Posted : May 22, 2009
Information provided by:

Brief Summary:
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis. Anemic patients on hemo and peritoneal dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing.

Condition or disease Intervention/treatment Phase
Kidney Disease Chronic Kidney Disease Drug: Darbepoetin Alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
Study Start Date : October 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: darbepoetin alfa Drug: Darbepoetin Alfa

QM administration for 32 weeks, allowable doses:

15, 20, 30, 40, 50, 60, 80, 100, 150, 200, 300, 400, 500, 600 and 800 mcg

Primary Outcome Measures :
  1. The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL and less than or equal to 13.0 g/dL during the evaluation phase [ Time Frame: entire study ]

Secondary Outcome Measures :
  1. Hb values over the duration of the study [ Time Frame: entire study ]
  2. Darbepoetin alfa doses over the duration of the study [ Time Frame: entire study ]
  3. Frequency and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure [ Time Frame: entire study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  • Transferrin saturation (Tsat) > 19.5%
  • Serum vitamin B12 and folate levels above the lower limit of the normal range
  • Receiving stable Q2W IV or SC doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to 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 greater than 110 mm Hg or systolic BP greater than 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 greater than 1500 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096915

Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00096915    
Other Study ID Numbers: 20040202
First Posted: November 18, 2004    Key Record Dates
Last Update Posted: May 22, 2009
Last Verified: May 2009
Keywords provided by Amgen:
chronic kidney disease, CKD
renal failure
peritoneal dialysis
Aranesp®, Darbepoetin Alfa
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa