Fixed Dose NESP Study in Subjects With CRI

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.

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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 less than 40 mL/min
Hemoglobin less than 11.0 g/dL
Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion criteria

Received rHuEPO therapy in the last 12 weeks
Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
Uncontrolled hypertension
Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding

Treatment and study plan

darbepoetin alfa

Drug

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

Primary outcomes

To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI

Time frame: entire study - 24 weeks

Secondary outcomes

To assess the safety and tolerability of chronic NESP therapy

Time frame: entire study - 24 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)

Important dates

Study start: 2000
Primary completion: 2002
Study completion: 2002
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