A Multicenter, Single-Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

Amgen0 sites110 target enrollmentOctober 2004

ConditionsKidney Disease Chronic Kidney Disease

InterventionsDarbepoetin Alfa

DrugsDarbepoetin Alfa

Overview

Phase: Phase 3
Intervention: Darbepoetin Alfa
Conditions: Kidney Disease
Sponsor: Amgen
Enrollment: 110
Primary Endpoint: 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
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

November 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

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

Arms & Interventions

darbepoetin alfa

Intervention: Darbepoetin Alfa

Outcomes

Primary Outcomes

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 Outcomes

Hb values over the duration of the study(entire study)
Darbepoetin alfa doses over the duration of the study(entire study)
Frequency and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure(entire study)