Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

NCT01478971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2016-09-20

Study results available

Summary

The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Conditions

Interventions

DRUG

Epoetin

Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous \[IV\] or subcutaneous \[SC\]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of \<11 g/dL.

DRUG

Peginesatide

Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at \<11 g/dL.

Sponsors & Collaborators

Affymax
collaborator INDUSTRY
Takeda
lead INDUSTRY

Principal Investigators

Medical Director, Clinical Science · Takeda

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2011-10-31
Primary Completion: 2013-02-28
Completion: 2013-02-28

Countries

United States

Study Locations

More Related Trials

Entities

Diseases

Companies

Takeda