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Clinical Study of R744 to Hemodialysis Patients

NCT00491868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2009-02-02

No results posted yet for this study

Summary

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

Conditions

  • Hemodialysis Patients

Interventions

DRUG

R744

100μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

DRUG

R744

150μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

DRUG

rHuEPO

2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

DRUG

rHuEPO

4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

DRUG

R744 placebo

0 μg/4week for 24 weeks

DRUG

rHuEPO placebo

0 IU 2 or 3 times/week for 8 weeks, then 1\~3 times/week for 16 weeks

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Takanori Baba · Chugai Pharmaceutical,Clinical Research Department 2

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-05-31
Completion
2008-08-31

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 NCT00491868 on ClinicalTrials.gov