Status:
COMPLETED
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00858637
Start Date
March 1 2009
End Date
March 1 2010
Last Update
January 7 2026
Active Locations (39)
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Brest, Belarus
2
Grodno, Belarus
3
Homyel, Belarus
4
Minsk, Belarus