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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Intervention / Treatment
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* Drug: MCI-196
* Drug: Another Phosphate binder (Sevelamer)


Participation Criteria
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Eligibility Criteria
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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.
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MCI-196<br>* 3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose<br>* Other names: BindRen®;|
| Active Comparator: 2<br> | Drug: Another Phosphate binder (Sevelamer)<br>* Current approved dosing recommendations for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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