Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

Completed

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Key information

Conditions

Kidney Disease Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
Anemic
Currently on erythropoietic therapy
Controlled hypertension
Clinically stable

Treatment and study plan

darbepoetin alfa SF

Drug

Frequency of dosing depends on frequency at randomization:

rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL

Primary outcomes

To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile

Time frame: Entire Study

Secondary outcomes

To characterize laboratory parameters in subjects with CKD

Time frame: Entire Study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Oct 11, 2004
Registry last updated: May 24, 2013

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