Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tanabe Pharma Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis