Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

NCT00121602

Anemia Kidney Disease

COMPLETED PHASE3

Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis

NCT00096915

Kidney Disease Chronic Kidney Disease

COMPLETED PHASE3

Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

NCT00436995

Chronic Kidney Disease

COMPLETED PHASE3

Darbepoetin Alfa Treatment of Anemia in Hemodialysis Subjects

NCT00119587

Anemia

COMPLETED PHASE3

Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

NCT00925587

Anemia Chronic Kidney Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Disease Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

darbepoetin alfa SF

Group Type EXPERIMENTAL

darbepoetin alfa SF

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

darbepoetin alfa SF

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No