Phase 2 Study of Darbepoetin Alfa Extended Dosing

Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.

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Key information

Conditions

Pre-dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Greater than or equal to 18 years of age
CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
Stable once every other week darbepoetin alfa SC for at least 6 weeks
Hb values during screening / baseline of 10.0 - 12.0 g/dL
Serum B12 and folate levels above the lower limit of normal and iron replete

Exclusion criteria

Receiving renal replacement therapy
Uncontrolled hypertension
Hyperparathyroidism
Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
Current malignancy
Pregnant or breast-feeding

Treatment and study plan

darbepoetin alfa

Drug

starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL

Primary outcomes

To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks

Time frame: Study weeks 21 - 29

Secondary outcomes

To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.

Time frame: Entire study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 10, 2007
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