At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 150 target

Drug / intervention

Darbepoetin Alfadrug

Likely dose

Darbepoetin Alfa 13.0 gfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00111098

NCT00111098Phase 3Completed

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A Multicenter, Single Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing In Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis

Amgen·interventional·Posted May 18, 2005·Updated Aug 8, 2008

In Brief

A Phase 3 clinical trial evaluating Darbepoetin Alfa for Kidney Disease. Completed, enrolled 150 participants.

Detailed Summary

The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who have achieved and maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsKidney Disease

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2004

First PostedMay 2005

Primary CompletionNov 2005

TodayJul 2026

First PostedMay 18, 2005

Enrollment StartMar 1, 2004

Primary CompletionNov 1, 2005

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 21.1 years ago

Interventions

Darbepoetin Alfadrug

QM administration for 28 weeks, adjusted as necessary to maintain Hb between 11.0 - 13.0 g/dL PFS concentrations: 20, 30, 40, 50, 60, 80, 100, 150, 200 and 300 mcg.