Phase 2 Study of Darbepoetin Alfa Extended Dosing

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527215

Enrollment

Registered

2007-09-10

Start date

2002-03-31

Completion date

2003-10-31

Last updated

2009-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Dialysis

Brief summary

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.

Interventions

DRUGdarbepoetin alfa

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Study weeks 21 - 29

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026