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

Primary Purpose

Chronic Kidney Disease, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Placebo
Another phosphate binder (Sevelamer)
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
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 Outcome Measures

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

Full Information

First Posted
December 27, 2006
Last Updated
October 28, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00416520
Brief Title
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hyperphosphatemia
Keywords
Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Intervention Description
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Intervention Type
Drug
Intervention Name(s)
Another phosphate binder (Sevelamer)
Intervention Description
Current approved dosing recommendations for 12 weeks
Primary Outcome Measure Information:
Title
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
Description
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.
Time Frame
week16 minus week12
Secondary Outcome Measure Information:
Title
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)
Description
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.
Time Frame
week12 minus week0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor
Organizational Affiliation
Information at Mitsubishi Pharma Europe
Official's Role
Principal Investigator
Facility Information:
City
Adelaide
Country
Australia
City
Nedlands
Country
Australia
City
Parkville
Country
Australia
City
St Leonards
Country
Australia
City
Sydney
Country
Australia
City
Woolloongabba
Country
Australia
City
Graz
Country
Austria
City
Frydek-Mistek
Country
Czech Republic
City
HradecKralove
Country
Czech Republic
City
Ostrava
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Tabor
Country
Czech Republic
City
Usti nad Labem
Country
Czech Republic
City
Bordeaux
Country
France
City
Montpelier
Country
France
City
Paris
Country
France
City
Aachen
Country
Germany
City
Aschaffenburg
Country
Germany
City
Coburg
Country
Germany
City
Coesfeld
Country
Germany
City
Darmstadt
Country
Germany
City
Dieburg
Country
Germany
City
Dortmund
Country
Germany
City
Dusseldorf
Country
Germany
City
Hamburg
Country
Germany
City
Homberg - Efze
Country
Germany
City
Langen
Country
Germany
City
Mannheim-Kafertal
Country
Germany
City
Munchen
Country
Germany
City
Potsdam-Babelsberg
Country
Germany
City
Baja
Country
Hungary
City
Budapest
Country
Hungary
City
Kisvarda
Country
Hungary
City
Veszprem
Country
Hungary
City
Biella
Country
Italy
City
Como
Country
Italy
City
Cremona
Country
Italy
City
Lecco
Country
Italy
City
Livorno
Country
Italy
City
Milan
Country
Italy
City
Pavia
Country
Italy
City
Perugia
Country
Italy
City
Rome
Country
Italy
City
Ciechanow
Country
Poland
City
Czestochowa
Country
Poland
City
Gdansk
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Oswiecim
Country
Poland
City
Pabianice
Country
Poland
City
Rybnik
Country
Poland
City
Sokolow Podlaski
Country
Poland
City
Starogard Gdanski
Country
Poland
City
Warszawa
Country
Poland
City
Wejherowo
Country
Poland
City
Zgierz
Country
Poland
City
Zielona Gora
Country
Poland
City
Cape Town
Country
South Africa
City
Durban
Country
South Africa
City
Gauteng
Country
South Africa
City
Johannesburg
Country
South Africa
City
Port Elizabeth
Country
South Africa
City
Barcelona
Country
Spain
City
Oviedo
Country
Spain
City
Sevilla
Country
Spain
City
Glasgow
Country
United Kingdom
City
Stevenage
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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