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A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

NCT00542386 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2026-01-08

Study results available
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Summary

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Conditions

Interventions

DRUG

MCI-196

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

DRUG

Placebo

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Pharma Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Hungary
  • Italy
  • Malaysia
  • North Macedonia
  • Poland
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

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 NCT00542386 on ClinicalTrials.gov