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

December 15, 2025 updated by: Tanabe Pharma Corporation

A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

642

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Ajka, Hungary
      • Baja, Hungary
      • Budapest, Hungary
      • Esztergom, Hungary
      • Győr, Hungary
      • Hatvan, Hungary
      • Kisvárda, Hungary
  • Italy
      • Lecco, Italy
      • Modena, Italy
      • Pavia, Italy
      • Roma, Italy
  • Malaysia
      • Alor Star, Malaysia
      • Ipoh, Malaysia
      • Kajang, Malaysia
      • Klang, Malaysia
      • Kota Kinabalu, Malaysia
      • Kuala Terengganu, Malaysia
      • Kuantan, Malaysia
      • Kuching, Malaysia
      • Malacca, Malaysia
      • Seremban, Malaysia
      • Taiping, Malaysia
  • North Macedonia
      • Skopje, North Macedonia
  • Poland
      • Lodz, Poland
      • Poznan, Poland
      • Płock, Poland
      • Rybnik, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
      • Zielona Góra, Poland
  • Russia
      • Arkhangelsk, Russia
      • Armavir, Russia
      • Chelyabinsk, Russia
      • Chita, Russia
      • Irkutsk, Russia
      • Ivanovo, Russia
      • Kaluga, Russia
      • Kemerovo, Russia
      • Khabarovsk, Russia
      • Krasnodar, Russia
      • Krasnoyarsk, Russia
      • Moscow, Russia
      • Nizhny Novgorod, Russia
      • Novokuznetsk, Russia
      • Novorossiysk, Russia
      • Novosibirsk, Russia
      • Omsk, Russia
      • Petrozavodsk, Russia
      • Rostov-on-Don, Russia
      • Saint Petersburg, Russia
      • Smolensk, Russia
      • Tomsk, Russia
      • Tver', Russia
      • Tyumen, Russia
      • Vladimir, Russia
      • Vladivostok, Russia
      • Volzhskiy, Russia
      • Yaroslavl, Russia
      • Yekaterinburg, Russia
  • Serbia
      • Belgrade, Serbia
      • Kragujevac, Serbia
      • Niš, Serbia
      • Novi Sad, Serbia
  • Ukraine
      • Chernivtsi, Ukraine
      • Dnipro, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Mykolaiv, Ukraine
      • Ternopil, Ukraine
      • Uzhhorod, Ukraine
      • Zaporizhya, Ukraine
      • Zhytomyr, Ukraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  • A a serum albumin level<30.0g/L
  • A PTH level >1000pg/mL
  • A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡
  • A serum LDL-C level >4.94mmol/L(190mg/dL)
  • A serum triglycerides level >6.76mmol/L (600mg/dL)
  • A 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Other Names:
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®
  • Colestilan(INN),
Placebo Comparator: 2
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Serum Phosphorus
Time Frame: 12 weeks
The change from baseline to week 12
12 weeks
The Change in LDL-cholesterol
Time Frame: 12 weeks
The percentage change from baseline to week 12
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The Change in Total-cholesterol
Time Frame: 12 weeks
12 weeks
The Change in HDL-cholesterol
Time Frame: 12 weeks
12 weeks
The Change in Triglycerides
Time Frame: 12 weeks
12 weeks
The Change in PTH
Time Frame: 12 weeks
12 weeks
The Change in Ca
Time Frame: 12 weeks
12 weeks
The Change in Ca x P Ion Product
Time Frame: 12 weeks
12 weeks
The Incidence of Adverse Events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Investigators

  • Principal Investigator: Professor, Information at Mitsubishi Pharma Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimated)

October 11, 2007

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI-196-E08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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