A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Phase 3

Completed

• Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia
• Interventions: Drug: MCI-196; Drug: Another Phosphate binder (Sevelamer)

• Registration Number: NCT00542815
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Detailed Description

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Study Timeline

• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-12
• Study Start: 2007-11
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2014-09
• Results First Submitted: 2014-09-16
• Results First Submitted QC: 2014-09-16
• Results First Posted: 2014-09-23
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 632

Inclusion Criteria

• Clinically stable haemodialysis or peritoneal dialysis treatment.
• Stable phosphate control
• Stabilised phosphorus diet.
• female subjects of child-bearing potential must have a negative serum pregnancy test.
• Male subjects must agree to use appropriate contraception.
• Completed one of the MCI-196 PIII studies

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.
• Current or a history of significant gastrointestinal motility problems
• Positive test for HIV 1 and 2 antibodies.
• History of substance or alcohol abuse within the last year.
• Seizure disorders.
• History of drug or other allergy.
• Temporary catheter with active signs of inflammation or infection.
• The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MCI-196	-
2	Another Phosphate binder (Sevelamer)	-

Primary Outcome Measures

Name	Time	Method
The Change in Serum Phosphorus for MCI-196 and Sevelamer	52 weeks (Baseline-52 weeks)	Change from Baseline to Week 52 (LOCF)

Secondary Outcome Measures

Name	Time	Method
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	52 weeks (Baseline-52 weeks)	Percent Change from Baseline to Week 52 (LOCF)