A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

Study Overview
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Brief Summary
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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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in 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: Placebo


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 has Stable phosphate control Subjects on Stabilized phosphorus diet Subjects undergoing regular dialysis treatment 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. serum albumin level < 3.0g/dL 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 hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies A clinically significant severe lactose intolerance or sensitivity 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MCI-196<br>* 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind<br>* Other names: BindRen®;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Serum Phosphorus From Week 12 to Week 16 | The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12) | 4 weeks (Week 12 to Week 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Phosphorus |  | 12 weeks (Week 0 to Week 12) | 
| Change From Baseline in PTH |  | 12 weeks | 
| Change From Baseline in Calcium |  | 12 weeks | 
| Change From Baseline in Calcium x Phosphorus Ion Product |  | 12 weeks | 
| Change From Baseline in Total Cholesterol |  | 12 weeks | 
| Change From Baseline in LDL Cholesterol |  | 12 weeks | 
| Change From Baseline in HDL Cholesterol |  | 12 weeks | 
| Change From Baseline in VLDL Cholesterol |  | 12 weeks | 
| Change From Baseline in Triglyceride |  | 12 weeks | 
| Incidence of Adverse Events |  | 12 weeks (Week 0-12) and 4 weeks (Week 12-16) | 

 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