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Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

NCT01101113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2012-06-08

No results posted yet for this study

Summary

This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

cinacalcet

cinacalcet 25mg qd or 50 mg qd

DRUG

control

vit D + P binder

Sponsors & Collaborators

  • Jeil-Kirin Pharmaceutical Inc.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • South Korea

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 NCT01101113 on ClinicalTrials.gov