Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
NCT ID: NCT00772382
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2008-12-31
2010-08-31
Brief Summary
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The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MCI-196
MCI-196
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Interventions
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MCI-196
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Professor
Role: PRINCIPAL_INVESTIGATOR
Information at Mitsubishi Pharma America
Locations
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Los Angeles, California, United States
Orange, California, United States
Tarzana, California, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Gurnee, Illinois, United States
Evansville, Indiana, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Northport, New York, United States
Durham, North Carolina, United States
Oklahoma City, Oklahoma, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Burlington, Vermont, United States
Chesapeake, Virginia, United States
Kamloops, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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Locatelli F, Spasovski G, Dimkovic N, Wanner C. Long-Term Evaluation of Colestilan in Chronic Kidney Disease Stage 5 Dialysis Patients with Hyperphosphataemia. Blood Purif. 2016;41(4):247-53. doi: 10.1159/000441648. Epub 2015 Dec 16.
Other Identifiers
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MCI-196-A06
Identifier Type: -
Identifier Source: org_study_id
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