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

Primary Purpose

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MCI-196

Arm Description

Outcomes

Primary Outcome Measures

Number of Adverse Events (AE)

Secondary Outcome Measures

The Change in Serum Phosphorus From Baseline to Week 52

Full Information

First Posted
October 10, 2008
Last Updated
September 5, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00772382
Brief Title
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Keywords
Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCI-196
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MCI-196
Other Intervention Name(s)
Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
Intervention Description
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Primary Outcome Measure Information:
Title
Number of Adverse Events (AE)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
The Change in Serum Phosphorus From Baseline to Week 52
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor
Organizational Affiliation
Information at Mitsubishi Pharma America
Official's Role
Principal Investigator
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Tarzana
State/Province
California
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Gurnee
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Northport
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
City
Kamloops
State/Province
British Columbia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26670307
Citation
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.
Results Reference
derived

Learn more about this trial

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

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