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

Trial Profile

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: 29 Sep 2017

At a glance

  • Drugs Apabetalone (Primary)
  • Indications Renal failure
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Resverlogix Corporation
  • Most Recent Events

    • 26 Sep 2017 Planned initiation date changed from 15 Sep 2017 to 15 Dec 2017.
    • 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.
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