Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00096915

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 III

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, 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

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
darbepoetin alfa: Experimental	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096915

Locations

Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Research Site
Calgary, Alberta, Canada
Canada, British Columbia
Research Site
Kamloops, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Research Site
Saint John, New Brunswick, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Sudbury, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Canada, Quebec
Research Site
Sherbrooke, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040202
Study First Received:	November 17, 2004
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00096915
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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009