A Two-Part Phase 2a Study in Patients With End-Stage Renal Disease Treated With Hemodialysis; Part A is an Open-Label Study Arm to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of 100 mg RVX000222; and Part B is a Double-Blind, Randomized, Placebo-Controlled, Sequential Cross-Over Study Arm to Evaluate the Efficacy, Safety, and Pharmacokinetics of RVX000222
Not yet recruiting
Phase of Trial: Phase II
Latest Information Update: 11 Jul 2017
At a glance
- Drugs Apabetalone (Primary)
- Indications Renal failure
- Focus Pharmacodynamics; Pharmacokinetics
- Sponsors Resverlogix Corporation
- 05 Jul 2017 Planned initiation date changed from 15 Jun 2017 to 15 Sep 2017.
- 15 May 2017 According to a Resverlogix media release, the Cardiovascular and Renal Products Division of the U.S. FDA has accepted IND application to commence this trial.
- 23 Feb 2017 According to a Resverlogix media release, FDA granted a positive receipt of an in-person Type B meeting on design issues relating to proposed protocol for its phase 2a kidney dialysis trial.