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Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

NCT00752791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2012-08-15

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of peginesatide injection for maintenance treatment of anemia in participants on peritoneal dialysis.

Conditions

Interventions

DRUG

Peginesatide

Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.

Sponsors & Collaborators

  • Affymax

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Australia
  • Italy
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00752791 on ClinicalTrials.gov