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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT00772382

First received: October 10, 2008

Last updated: December 4, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2008

Last Updated Date

December 4, 2011

Start Date ^ICMJE

December 2008

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse events, vital signs, ECG-parameters, clinical laboratory parameters and physical examination [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00772382 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The change in serum phosphorus, LDL-cholesterol, other lipid parameters, PTH, calcium and calcium-phosphorus ion product [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase III, Multi-center, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Kidney Disease
Dialysis
Hyperphosphatemia

Intervention ^ICMJE

Drug: MCI-196

3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

Other Names:

Colestilan(INN)
Colestimide(JAN)
CHOLEBINE®

Study Arm (s)

Experimental: MCI-196

Intervention: Drug: MCI-196

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

116

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00772382

Other Study ID Numbers ^ICMJE

MCI-196-A06

Has Data Monitoring Committee

Responsible Party

Mitsubishi Tanabe Pharma Corporation

Study Sponsor ^ICMJE

Mitsubishi Tanabe Pharma Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Professor

Information at Mitsubishi Pharma America

Information Provided By

Mitsubishi Tanabe Pharma Corporation

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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