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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The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia. The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Official Title
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A Phase III, Multi-center, 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, and is >=18 years old Stable hemodialysis or peritoneal dialysis Subjects have stable phosphate control Subjects on stabilized phosphorus diet Subjects undergoing regular dialysis treatment Females 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 him/her 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 serum albumin level < 3.0g/L PTH level > 1000pg/mL Hemoglobin level < 8mg/dL A History of significant gastrointestinal motility problems Biliary obstruction or proven liver dysfunction 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 using cholestyramine, colestipol or colesevelam Schedule to receive a kidney transplant within the next 6 months Participation 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
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCI-196<br> | Drug: MCI-196<br>* 3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose<br>* Other names: BindRen®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AE) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Serum Phosphorus From Baseline to Week 52 |  | 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, Phosphate binder