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

Phase 3

Completed

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

• Registration Number: NCT00506441
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-25
• Study Start: 2007-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Disposition First Submitted: 2010-05-26
• Disposition First Submitted QC: 2010-06-07
• Disposition First Posted: 2010-06-08
• Results First Submitted: 2014-04-10
• Results First Submitted QC: 2014-06-26
• Results First Posted: 2014-07-25
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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.

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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.
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MCI-196	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
The Change in Serum Phosphorus From Week 12 to Week 16	4 weeks (Week 12 to Week 16)	The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)

Secondary Outcome Measures

Name	Time	Method
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 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)
Change From Baseline in Total Cholesterol	12 weeks