MedTrace Logo

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

NCT00542815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2026-01-07

Study results available
· View outcomes & findings →

Summary

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Conditions

Interventions

DRUG

MCI-196

3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose

DRUG

Another Phosphate binder (Sevelamer)

Current approved dosing recommendations for 12 weeks

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Pharma Europe

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Austria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Malaysia
  • North Macedonia
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00542815 on ClinicalTrials.gov