Skip to main content
OpenTrials
Completed

NCT Number: NCT00416520

A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

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, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age or over
  • Clinically stable haemodialysis or peritoneal dialysis
  • Stable phosphate control
  • On a stabilised phosphorus diet
  • Female and of child-bearing potential have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.

Exclusion criteria

  • Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
  • Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
  • A current or history of significant gastrointestinal motility problems
  • A positive test for HIV 1 and 2 antibodies
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders
  • A history of drug or other allergy
  • A temporary catheter as a vascular access
  • Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Treatment and study plan

MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)

Drug

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

Placebo

Drug

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

Another phosphate binder (Sevelamer)

Drug

Current approved dosing recommendations for 12 weeks

Primary outcomes

  1. Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)

    Time frame: week16 minus week12

    ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.

Secondary outcomes

  1. Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)

    Time frame: week12 minus week0

    ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 28, 2006
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.