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A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

Primary Purpose

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196
Placebo
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 has Stable phosphate control
  • Subjects on Stabilized phosphorus diet
  • Subjects undergoing regular dialysis treatment
  • Female 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 them 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/dL
  • 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 hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
  • A clinically significant severe lactose intolerance or sensitivity
  • 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 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The Change in Serum Phosphorus From Week 12 to Week 16
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)

Secondary Outcome Measures

Change From Baseline in Serum Phosphorus
Change From Baseline in PTH
Change From Baseline in Calcium
Change From Baseline in Calcium x Phosphorus Ion Product
Change From Baseline in Total Cholesterol
Change From Baseline in LDL Cholesterol
Change From Baseline in HDL Cholesterol
Change From Baseline in VLDL Cholesterol
Change From Baseline in Triglyceride
Incidence of Adverse Events

Full Information

First Posted
July 24, 2007
Last Updated
September 5, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00506441
Brief Title
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in 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
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
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, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Primary Outcome Measure Information:
Title
The Change in Serum Phosphorus From Week 12 to Week 16
Description
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Time Frame
4 weeks (Week 12 to Week 16)
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum Phosphorus
Time Frame
12 weeks (Week 0 to Week 12)
Title
Change From Baseline in PTH
Time Frame
12 weeks
Title
Change From Baseline in Calcium
Time Frame
12 weeks
Title
Change From Baseline in Calcium x Phosphorus Ion Product
Time Frame
12 weeks
Title
Change From Baseline in Total Cholesterol
Time Frame
12 weeks
Title
Change From Baseline in LDL Cholesterol
Time Frame
12 weeks
Title
Change From Baseline in HDL Cholesterol
Time Frame
12 weeks
Title
Change From Baseline in VLDL Cholesterol
Time Frame
12 weeks
Title
Change From Baseline in Triglyceride
Time Frame
12 weeks
Title
Incidence of Adverse Events
Time Frame
12 weeks (Week 0-12) and 4 weeks (Week 12-16)

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 has Stable phosphate control Subjects on Stabilized phosphorus diet Subjects undergoing regular dialysis treatment Female 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 them 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/dL 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 hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies A clinically significant severe lactose intolerance or sensitivity 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
Glendale
State/Province
Arizona
Country
United States
City
Tempe
State/Province
Arizona
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
Paragould
State/Province
Arkansas
Country
United States
City
Pine Bluff
State/Province
Arkansas
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Lynwood
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Hudson
State/Province
Florida
Country
United States
City
Lauderdale Lakes
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Decatur
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Evergreen Park
State/Province
Illinois
Country
United States
City
Fort Wayne
State/Province
Indiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Eatontown
State/Province
New Jersey
Country
United States
City
Flushing
State/Province
New York
Country
United States
City
Springfield Gardens
State/Province
New York
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Lewistown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Sumter
State/Province
South Carolina
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Alexandria
State/Province
Virginia
Country
United States
City
Portsmouth
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
West Allis
State/Province
Wisconsin
Country
United States
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
26184491
Citation
Hertel J, Locatelli F, Spasovski G, Dimkovic N, Wanner C. Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia. Nephron. 2015;130(4):229-38. doi: 10.1159/000431289. Epub 2015 Jul 10.
Results Reference
derived

Learn more about this trial

A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

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