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

Phase 3

Completed

• Conditions: Dialysis; Hyperphosphatemia; Dyslipidemia; Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: MCI-196

• Registration Number: NCT00542386
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Study Start: 2007-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Disposition First Submitted: 2010-06-24
• Disposition First Submitted QC: 2010-06-24
• Disposition First Posted: 2010-06-25
• Results First Submitted: 2014-04-10
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Results First Posted: 2014-10-06
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	MCI-196	-

Primary Outcome Measures

Name	Time	Method
The Change in Serum Phosphorus	12 weeks	The change from baseline to week 12
The Change in LDL-cholesterol	12 weeks	The percentage change from baseline to week 12

Secondary Outcome Measures

Name	Time	Method
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