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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
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)
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)
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)
Unnamed facility
Brest, Belarus
Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)
Percent Change from Week 16 to Week 20 (LOCF)
Time frame: week20 minus week16
Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)
Percent Change from Baseline to Week 16 (LOCF)
Time frame: week16 minus week0
Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)
Time frame: 16 weeks and 20 weeks
Vital Signs, Adverse Events, and Laboratory Values
Time frame: throughout study
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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)
Unnamed facility
Grodno, Belarus
Unnamed facility
Homyel, Belarus
Unnamed facility
Minsk, Belarus
Unnamed facility
Vitebsk, Belarus
Unnamed facility
Gabrovo, Bulgaria
Unnamed facility
Plovdiv, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Karlovac, Croatia
Unnamed facility
Osijek, Croatia
...and 29 more locations