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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00096915
First received: November 17, 2004
Last updated: May 21, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Kidney Disease
Chronic Kidney Disease
Drug: Darbepoetin Alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hb values over the duration of the study [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Darbepoetin alfa doses over the duration of the study [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • Frequency and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure [ Time Frame: entire study ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: October 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
  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: NCT00096915

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: NCT00096915     History of Changes
Other Study ID Numbers: 20040202
Study First Received: November 17, 2004
Last Updated: May 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
chronic kidney disease, CKD
renal failure
anemia
hemodialysis
peritoneal dialysis
Aranesp®, Darbepoetin Alfa

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

ClinicalTrials.gov processed this record on September 18, 2014