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

Phase 3

Completed

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

• Registration Number: NCT00772382
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Study Start: 2008-12
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Disposition First Submitted: 2011-12-04
• Disposition First Submitted QC: 2011-12-04
• Disposition First Posted: 2011-12-08
• Results First Submitted: 2014-04-10
• Results First Submitted QC: 2014-04-10
• Results First Posted: 2014-05-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Male or female, and is >=18 years old
• Stable hemodialysis or peritoneal dialysis
• Subjects have stable phosphate control
• Subjects on stabilized phosphorus diet
• Subjects undergoing regular dialysis treatment
• Females 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 him/her 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/L
• 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 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCI-196	MCI-196	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AE)	52 weeks

Secondary Outcome Measures

Name	Time	Method
The Change in Serum Phosphorus From Baseline to Week 52	52 weeks