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

September 24, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

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

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Study Type

Interventional

Enrollment (Actual)

632

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

  • Austria
      • Graz, Austria
  • Czech Republic
      • Frydek-Mistek, Czech Republic
      • Hradec Kralove, Czech Republic
      • Ostrava, Czech Republic
      • Praha, Czech Republic
      • Tabor, Czech Republic
      • Usti nad Labem, Czech Republic
  • France
      • Bordeaux, France
      • Montpelier, France
      • Paris, France
  • Germany
      • Aschaffenburg, Germany
      • Coesfeld, Germany
      • Darmstadt, Germany
      • Dortmund, Germany
      • Dusseldorf, Germany
      • Hamburg, Germany
      • Homberg-Efze, Germany
      • Langen, Germany
      • Mannheim-Kafertal, Germany
  • Hungary
      • Ajka, Hungary
      • Baja, Hungary
      • Budapest, Hungary
      • Esztergom, Hungary
      • Gyor, Hungary
      • Hatvan, Hungary
      • Kisvarda, Hungary
      • Veszprem, Hungary
  • Italy
      • Ancona, Italy
      • Cernusco sul Naviglio, Italy
      • Como, Italy
      • Cremona, Italy
      • Lecco, Italy
      • Livorno, Italy
      • Milan, Italy
      • Modena, Italy
      • Ostia Roma, Italy
      • Pavia, Italy
      • Perugia, Italy
      • Rome, Italy
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
  • Malaysia
      • Alor Setar, Malaysia
      • Klang, Malaysia
      • Kota Kinabalu, Malaysia
      • Kuala Terengganu, Malaysia
      • Kuching, Malaysia
      • Melaka, Malaysia
      • Selangor Darul Ehsan, Malaysia
      • Seremban, Malaysia
      • Taiping, Malaysia
  • Poland
      • Ciechanow, Poland
      • Czestochowa, Poland
      • Gdansk, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Oswiecim, Poland
      • Pabianice, Poland
      • Poznan, Poland
      • Rybnik, Poland
      • Sokolow Podlaski, Poland
      • Starogard Gdanski, Poland
      • Warszawa, Poland
      • Wejherowo, Poland
      • Wroclaw, Poland
      • Zgierz, Poland
      • Zielona Gora, Poland
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Chita, Russian Federation
      • Ekaterinburg, Russian Federation
      • Irkutsk, Russian Federation
      • Ivanovo, Russian Federation
      • Kaluga, Russian Federation
      • Karbysheva str.Volzskiy, Russian Federation
      • Kemerovo, Russian Federation
      • Khabarovsk, Russian Federation
      • Krasnodar, Russian Federation
      • Krasnoyarsk, Russian Federation
      • Moscow, Russian Federation
      • Mytishchi, Russian Federation
      • Nizhniy Novgorod, Russian Federation
      • Novokuznetsk, Russian Federation
      • Novorossiysk, Russian Federation
      • Novosibirsk, Russian Federation
      • Omsk, Russian Federation
      • Petrozavodsk, Russian Federation
      • Rostov-on-Don, Russian Federation
      • Rozhkova, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • Tomsk, Russian Federation
      • Vladivostok, Russian Federation
      • Yaroslavl, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Kragujevac, Serbia
      • Nis, Serbia
      • Novi Sad, Serbia
  • 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
  • Ukraine
      • Chernivtsy, Ukraine
      • Dnepropetrovsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Mykolayiv, Ukraine
      • Ternopil, Ukraine
      • Uzhorod, Ukraine
      • Zaporizhya, Ukraine
      • Zhytomyr, Ukraine
  • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically stable haemodialysis or peritoneal dialysis treatment.
  • Stable phosphate control
  • Stabilised phosphorus diet.
  • female subjects of child-bearing potential must have a negative serum pregnancy test.
  • Male subjects must agree to use appropriate contraception.
  • Completed one of the MCI-196 PIII studies

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.
  • Current or a history of significant gastrointestinal motility problems
  • Positive test for HIV 1 and 2 antibodies.
  • History of substance or alcohol abuse within the last year.
  • Seizure disorders.
  • History of drug or other allergy.
  • Temporary catheter with active signs of inflammation or infection.
  • The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MCI-196
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Other Names:
  • Colestilan(INN)
  • Colestimide(JAN)
  • CHOLEBINE®
  • BindRen®
Active Comparator: 2
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
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Time Frame: 52 weeks (Baseline-52 weeks)
Change from Baseline to Week 52 (LOCF)
52 weeks (Baseline-52 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Time Frame: 52 weeks (Baseline-52 weeks)
Percent Change from Baseline to Week 52 (LOCF)
52 weeks (Baseline-52 weeks)

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

November 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimate)

October 12, 2007

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI-196-E10

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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