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A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

NCT00506441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-01-08

Study results available
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Summary

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Conditions

Interventions

DRUG

MCI-196

3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind

DRUG

Placebo

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Pharma America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Drugs
Diseases

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 NCT00506441 on ClinicalTrials.gov