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

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.

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Key information

Conditions

Kidney Disease Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

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

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

Time frame: entire study
Darbepoetin alfa doses over the duration of the study

Time frame: entire study
Frequency and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure

Time frame: entire study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Nov 18, 2004
Registry last updated: May 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed