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Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

NCT00492427 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2009-01-08

No results posted yet for this study

Summary

This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.

Conditions

  • Predialysis Patients

Interventions

DRUG

R744

25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25\~250μg(s.c.)/4week for 24\~26weeks in total.

DRUG

Epoetin beta

6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k\~12000IU(s.c.)/2week for 24\~26weeks in total.

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Takanori Baba · Chugai Pharmaceutical,Clinical Research Department 2

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-01-31
Completion
2008-11-30

Countries

  • Japan

Study Locations

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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 NCT00492427 on ClinicalTrials.gov