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Message: Renal Phase 2a Trial Now Listed on ClinicalTrial.gov

Renal Phase 2a Trial Now Listed on ClinicalTrial.gov. Thanks to Fundamentals6 for first reporting on InvestorVillage.

A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis

Purpose:

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.

Estimated Enrollment: 44 

Anticipated Study Start Date: June 15, 2017 

Estimated Study Completion Date: July 15, 2018 

Estimated Primary Completion Date: July 15, 2018 (Final data collection date for primary outcome measure) 

 

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