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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Kidney Disease, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
* Drug: Placebo
* Drug: Another phosphate binder (Sevelamer)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)<br>* 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind<br>|
| Active Comparator: 3<br> | Drug: Another phosphate binder (Sevelamer)<br>* Current approved dosing recommendations for 12 weeks<br>|

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) | 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) | 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 | 

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