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Clinical Trials/JPRN-jRCT2080223814
JPRN-jRCT2080223814CompletedPhase 3

Phase 3 Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study> (SYMPHONY ND)

Japan Tobacco Inc.0 sites216 target enrollmentStarted: February 19, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
216
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

SYMPHONY ND demonstrated that JTZ-951 was as effective as DA in maintaining Hb levels in anemic patients with CKD not requiring dialysis, and was generally well-tolerated over 24 weeks.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •ESA naive patients:
  • •Hemoglobin level of => 8.0 g/dL and =< 10.5 g/dL
  • •ESA treated patients:
  • •Hemoglobin level of => 9.5 g/dL and =< 12.0 g/d

Exclusion Criteria

  • •Patients with poorly controlled hypertension
  • •Patients with congestive heart failure or unstable angina
  • •Patients with malignancy

Investigators

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