A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Intervention / Treatment
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* Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose<br>|
| Experimental: 2<br> | Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)<br>* 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphorus change compared to placebo from baseline to week 12. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Dialysis, Hyperphosphatemia