Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disea… (NCT00858637) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
Belarus260 participantsStarted 2009-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)