A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

Phase 3

Completed

• Conditions: Hyperphosphatemia; Chronic Kidney Disease
• Interventions: Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®); Drug: Placebo; Drug: Another phosphate binder (Sevelamer)

• Registration Number: NCT00416520
• 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, randomised, parallel group, flexible dose, 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: 2006-12-27
• Study First Submitted QC: 2006-12-27
• Study First Posted: 2006-12-28
• Study Start: 2007-06
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2014-08-22
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-20
• Results First Posted: 2014-10-23
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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.
• Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
• A current or 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
1	MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)	-
2	Placebo	-
3	Another phosphate binder (Sevelamer)	-

Primary Outcome Measures

Name	Time	Method
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)	week16 minus week12	ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)	week12 minus week0	ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.