Back to resultsEfficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196
Placebo of Simvastatin
Simvastatin
Placebo of MCI-196
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Dyslipidemia, Bile acid sequestrant
Eligibility Criteria
Inclusion Criteria:
- Male or female, and is >=18 years old
- Stable hemodialysis or peritoneal dialysis
- Subjects undergoing regular dialysis treatment
- If 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 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 < 30 g/L
- Triglycerides level > 6.76 mmol/L (600 mg/dL)
- LDL-cholesterol level > 4.94 mmol/L (190 mg/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
- The subject has a history of rhabdomyolysis or myopathy
- Schedule to receive a kidney transplant within the next 6 months
- The subject has porphyria
- 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 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
1 MCI-196
2 Placebo of MCI-196
3 Simvastatin
4 Placebo of Simvastatin
Arm Description
Outcomes
Primary Outcome Measures
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
Percent Change from Week 16 to Week 20 (LOCF)
Secondary Outcome Measures
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
Percent Change from Baseline to Week 16 (LOCF)
Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)
Vital Signs, Adverse Events, and Laboratory Values
Full Information
NCT ID
NCT00858637
First Posted
March 9, 2009
Last Updated
December 8, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00858637
Brief Title
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Official Title
A Phase III, Multicentre, Double-blind, Double-dummy, Randomised, Flexible-dose, Comparative Study of MCI-196 Versus Simvastatin for the Treatment of Dyslipidaemia in Subjects With Chronic Kidney Disease on Dialysis (Incorporating a Placebo-controlled Withdrawal Phase)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 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 superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Dialysis, Dyslipidemia, Bile acid sequestrant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 MCI-196
Arm Type
Experimental
Arm Title
2 Placebo of MCI-196
Arm Type
Placebo Comparator
Arm Title
3 Simvastatin
Arm Type
Active Comparator
Arm Title
4 Placebo of Simvastatin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MCI-196
Other Intervention Name(s)
Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
Intervention Description
Tablets of 3 g to 12 g/day (3 times a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Intervention Type
Drug
Intervention Name(s)
Placebo of Simvastatin
Intervention Description
Tablets once a day, for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
Tablets of 10 mg to 40 mg/day (once a day) with dose escalation design during 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Intervention Type
Drug
Intervention Name(s)
Placebo of MCI-196
Intervention Description
Tablets 3 times a day for 16 weeks of Active Comparison Phase, and 4 weeks of fixed dose during Withdrawal Phase (Week 16 to Week 20)
Primary Outcome Measure Information:
Title
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
Description
Percent Change from Week 16 to Week 20 (LOCF)
Time Frame
week20 minus week16
Secondary Outcome Measure Information:
Title
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
Description
Percent Change from Baseline to Week 16 (LOCF)
Time Frame
week16 minus week0
Title
Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)
Time Frame
16 weeks and 20 weeks
Title
Vital Signs, Adverse Events, and Laboratory Values
Time Frame
throughout study
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 undergoing regular dialysis treatment
If 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 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 < 30 g/L
Triglycerides level > 6.76 mmol/L (600 mg/dL)
LDL-cholesterol level > 4.94 mmol/L (190 mg/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
The subject has a history of rhabdomyolysis or myopathy
Schedule to receive a kidney transplant within the next 6 months
The subject has porphyria
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 Europe
Official's Role
Principal Investigator
Facility Information:
City
Brest
Country
Belarus
City
Gomel
Country
Belarus
City
Grodno
Country
Belarus
City
Minsk
Country
Belarus
City
Vitebsk
Country
Belarus
City
Gabrovo
Country
Bulgaria
City
Plovdiv
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Karlovac
Country
Croatia
City
Osijek
Country
Croatia
City
Esbjerg
Country
Denmark
City
Roskilde
Country
Denmark
City
Jakarta
Country
Indonesia
City
Malang
Country
Indonesia
City
Medan
Country
Indonesia
City
Palembang
Country
Indonesia
City
Tamanlarea Makassar
Country
Indonesia
City
Ashkelon
Country
Israel
City
Nahariya
Country
Israel
City
Bellano
Country
Italy
City
Catania
Country
Italy
City
Lecco
Country
Italy
City
Merate
Country
Italy
City
Milano
Country
Italy
City
Oggiono
Country
Italy
City
Riga
Country
Latvia
City
Valmiera
Country
Latvia
City
Kaunas
Country
Lithuania
City
Kedauniai
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Johor
Country
Malaysia
City
Kelantan
Country
Malaysia
City
Penang
Country
Malaysia
City
Perak
Country
Malaysia
City
Bucharest
Country
Romania
City
Timisoara
Country
Romania
City
Singapore
Country
Singapore
City
Bangkok
Country
Thailand
City
Phitsanulok
Country
Thailand
12. IPD Sharing Statement
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Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
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