A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis
Status:
Unknown status
Trial end date:
2021-03-15
Target enrollment:
Participant gender:
Summary
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.