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

NCT ID: NCT00096915

Last Updated: 2009-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-11-30

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.

Conditions

Kidney Disease; Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

darbepoetin alfa

Group Type: EXPERIMENTAL

Darbepoetin Alfa

Intervention Type: DRUG

QM administration for 32 weeks, allowable doses:

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Amgen Inc.

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20040202.pdf

To access clinical trial results information click on this link

http://www.aranesp.com/

FDA-approved Drug Labeling

Other Identifiers

20040202

Identifier Type: -

Identifier Source: org_study_id