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Fixed Dose NESP Study in Subjects With CRI

NCT00526929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2009-05-22

No results posted yet for this study

Summary

Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.

Conditions

  • Pre-Dialysis

Interventions

DRUG

darbepoetin alfa

10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-05-31
Primary Completion
2002-02-28
Completion
2002-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526929 on ClinicalTrials.gov