Back to resultsA Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
Primary Purpose
Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 to 80 years of age.
- Stable phosphate control using Calcium-based phosphate-binding medication only.
- The subject is undergoing regular dialysis treatment.
- On a stabilised phosphorus diet.
- If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
- 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.
- Current or a history of significant gastrointestinal motility problems
- A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- A history of substance or alcohol abuse within the last year.
- Seizure disorders.
- Using phosphate binder medication other than calcium based phosphate binders
- Using colestyramine, colestipol or colesevelam
- A history of drug or other allergy
- 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 the informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Serum phosphorus change compared to placebo from baseline to week 12.
Secondary Outcome Measures
Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.
Full Information
NCT ID
NCT00451295
First Posted
March 22, 2007
Last Updated
November 13, 2011
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00451295
Brief Title
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
Official Title
A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped because of insufficient enrollment.
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (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 study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Keywords
Chronic Kidney Disease, Dialysis, Hyperphosphatemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
Primary Outcome Measure Information:
Title
Serum phosphorus change compared to placebo from baseline to week 12.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 to 80 years of age.
Stable phosphate control using Calcium-based phosphate-binding medication only.
The subject is undergoing regular dialysis treatment.
On a stabilised phosphorus diet.
If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
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.
Current or a history of significant gastrointestinal motility problems
A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
A history of substance or alcohol abuse within the last year.
Seizure disorders.
Using phosphate binder medication other than calcium based phosphate binders
Using colestyramine, colestipol or colesevelam
A history of drug or other allergy
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 the 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
Frydek-Mistek
Country
Czech Republic
City
Ostrava
Country
Czech Republic
City
Bordeaux
Country
France
City
Montpelier
Country
France
City
Aachen
Country
Germany
City
Coburg
Country
Germany
City
Lecco
Country
Italy
City
Milan
Country
Italy
City
Pavia
Country
Italy
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
City
Gdansk
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Oswiecim
Country
Poland
City
Poznan
Country
Poland
City
Wejherowo
Country
Poland
City
Wroclaw
Country
Poland
City
Belgrade
Country
Serbia
City
Nis
Country
Serbia
City
Novisad
Country
Serbia
City
Cape Town
Country
South Africa
City
Gauteng
Country
South Africa
City
Barcelona
Country
Spain
City
Oviedo
Country
Spain
City
Stevenage
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
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