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

October 28, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

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

  • Australia
      • Adelaide, Australia
      • Nedlands, Australia
      • Parkville, Australia
      • St Leonards, Australia
      • Sydney, Australia
      • Woolloongabba, Australia
  • Austria
      • Graz, Austria
  • Czech Republic
      • Frydek-Mistek, Czech Republic
      • HradecKralove, Czech Republic
      • Ostrava, Czech Republic
      • Praha, Czech Republic
      • Tabor, Czech Republic
      • Usti nad Labem, Czech Republic
  • France
      • Bordeaux, France
      • Montpelier, France
      • Paris, France
  • Germany
      • Aachen, Germany
      • Aschaffenburg, Germany
      • Coburg, Germany
      • Coesfeld, Germany
      • Darmstadt, Germany
      • Dieburg, Germany
      • Dortmund, Germany
      • Dusseldorf, Germany
      • Hamburg, Germany
      • Homberg - Efze, Germany
      • Langen, Germany
      • Mannheim-Kafertal, Germany
      • Munchen, Germany
      • Potsdam-Babelsberg, Germany
  • Hungary
      • Baja, Hungary
      • Budapest, Hungary
      • Kisvarda, Hungary
      • Veszprem, Hungary
  • Italy
      • Biella, Italy
      • Como, Italy
      • Cremona, Italy
      • Lecco, Italy
      • Livorno, Italy
      • Milan, Italy
      • Pavia, Italy
      • Perugia, Italy
      • Rome, Italy
  • Poland
      • Ciechanow, Poland
      • Czestochowa, Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Oswiecim, Poland
      • Pabianice, Poland
      • Rybnik, Poland
      • Sokolow Podlaski, Poland
      • Starogard Gdanski, Poland
      • Warszawa, Poland
      • Wejherowo, Poland
      • Zgierz, Poland
      • Zielona Gora, Poland
  • South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Gauteng, South Africa
      • Johannesburg, South Africa
      • Port Elizabeth, South Africa
  • Spain
      • Barcelona, Spain
      • Oviedo, Spain
      • Sevilla, Spain
  • United Kingdom
      • Glasgow, United Kingdom
      • Stevenage, United Kingdom

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

Genders Eligible for Study

All

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.
  • 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

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 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
Placebo Comparator: 2
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Active Comparator: 3
Drug: Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week16 minus week12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week12 minus week0

Collaborators and Investigators

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

Sponsor

Mitsubishi Tanabe Pharma Corporation

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

June 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 27, 2006

First Submitted That Met QC Criteria

December 27, 2006

First Posted (Estimate)

December 28, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI-196-E07

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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Locations

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