A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Study Overview
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Brief Summary
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This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Official Title
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A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

Conditions
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Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia

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, 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. A a serum albumin level<30.0g/L A PTH level >1000pg/mL A body mass index (BMI)<= 16.0kg/㎡ or =>40.0kg/㎡ A serum LDL-C level >4.94mmol/L(190mg/dL) A serum triglycerides level >6.76mmol/L (600mg/dL) A 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
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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 fixed dose of study<br>* Other names: BindRen®;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Serum Phosphorus | The change from baseline to week 12 | 12 weeks | 
| The Change in LDL-cholesterol | The percentage change from baseline to week 12 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Total-cholesterol |  | 12 weeks | 
| The Change in HDL-cholesterol |  | 12 weeks | 
| The Change in Triglycerides |  | 12 weeks | 
| The Change in PTH |  | 12 weeks | 
| The Change in Ca |  | 12 weeks | 
| The Change in Ca x P Ion Product |  | 12 weeks | 
| The Incidence of Adverse Events |  | 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, Dyslipidemia, Phosphate binder