Phase 2 Study of Darbepoetin Alfa Extended Dosing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2003-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Pre-Dialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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darbepoetin alfa

Group Type EXPERIMENTAL

darbepoetin alfa

Intervention Type 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

Interventions

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darbepoetin 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No