This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care.
Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC.
The primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.
Men or women ≥18 and ≤80 years of age.
Diagnosis of end-stage renal disease and receiving hemodialysis an average of three (3) times per week for at least ninety (90) days prior to Enrollment/Visit 2.
Clinically stable, in the judgment of the investigator.
If of childbearing potential, must have a negative serum pregnancy test and be willing and able to use medically acceptable non-hormonal method of birth control (non-hormonal intrauterine device, condom, or diaphragm) or remain abstinent from Screen until Follow-up Visit, or
Planned major surgery in the next 4 months, including renal transplant, from Enrollment/Visit 2.
Major surgery, in the judgement of the investigator, within 12 weeks before enrollment/Visit 2 (excluding vascular access surgery).
Hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack or peripheral arterial disease within 6 months before Enrollment/Visit 2.
New York Heart Association (NYHA) Classification, Class III or IV Heart Failure at Screen/Visit 1.
Sequential
apabetalone
DrugRVX000222 oral (apabetalone), 100 mg capsule
Placebos
Drugmatching placebo capsule
Percent change in alkaline phosphatase (ALP) concentration (Part B)
The primary endpoint of the study is the comparison of the RVX000222 treatment period to the placebo period in the percent change in ALP concentration. Percent change is computed relative to the beginning of each period.
Single Dose Cmax of RVX000222 (apabetalone) and the Metabolites RVX000288 and RVX000404
Primary PK comparison between dialysis (test) and non-dialysis (reference) days for Cmax of RVX000222 and its two principal metabolites, RVX000288 and RVX000404
Single Dose AUC of RVX000222 (apabetalone) and the Metabolites RVX000288 and RVX000404
Primary PK comparison between dialysis (test) and non-dialysis (reference) days for AUC of RVX000222 and its two principal metabolites, RVX000288 and RVX000404
Changes in high-sensitivity C-Reactive Protein (hsCRP)
Changes in hsCRP in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period
Changes in Interleukin-13 (IL-13)
Changes in IL-13 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period
Changes in Interleukin-6 (IL-6)
Changes in IL-6 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period
Changes in Interleukin-8 (IL-8)
Changes in IL-8 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period
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