Skip to main content
OpenTrials
Completed

NCT Number: NCT00772382

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

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Dialysis 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

Kamloops, British Columbia, Canada

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, and is >=18 years old
  • Stable hemodialysis or peritoneal dialysis
  • Subjects have stable phosphate control
  • Subjects on stabilized phosphorus diet
  • Subjects undergoing regular dialysis treatment
  • Females 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 him/her 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
  • serum albumin level < 3.0g/L
  • PTH level > 1000pg/mL
  • Hemoglobin level < 8mg/dL
  • A History of significant gastrointestinal motility problems
  • Biliary obstruction or proven liver dysfunction
  • 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
  • using cholestyramine, colestipol or colesevelam
  • Schedule to receive a kidney transplant within the next 6 months
  • Participation 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

Drug

3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

Other names: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®

Primary outcomes

  1. Number of Adverse Events (AE)

    Time frame: 52 weeks

Secondary outcomes

  1. The Change in Serum Phosphorus From Baseline to Week 52

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Phase III, Multi-center, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2008
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.