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

This study is not yet open for participant recruitment.

Verified by Mitsubishi Tanabe Pharma Corporation, October 2008

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00772382

Purpose

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.

Condition	Intervention	Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia	Drug: MCI-196	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MCI-196: Experimental	Drug: MCI-196 3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772382

Contacts

Contact: Information at Mitsubishi Pharma America

MCI-196_A06@m-pharma.com

Locations

United States, California

Los Angeles, California, United States
United States, Indiana

Evansville, Indiana, United States
United States, Louisiana

New Orleans, Louisiana, United States
United States, New York

Northport, New York, United States
United States, North Carolina

Durham, North Carolina, United States
United States, Vermont

Burlington, Vermont, United States
Canada, Ontario

Toronto, Ontario, Canada

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Principal Investigator:

Professor

Information at Mitsubishi Pharma America

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( Study Project Manager )
Study ID Numbers:	MCI-196-A06
Study First Received:	October 10, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00772382
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Phosphate binder

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009