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

Amgen

Status and phase

Completed

Phase 3

Conditions

Chronic Kidney Disease

Kidney Disease

Treatments

Drug: Darbepoetin Alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00096915

20040202

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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