Clinical Trial: A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia

Brief Summary: This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).

Detailed Summary: The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.
Sponsor: Ardelyx

Current Primary Outcome: Exponential Rate of Change in Serum Potassium from Baseline [ Time Frame: 48 hours ]

Onset of Action


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Serum Potassium Levels [ Time Frame: 7 days ]
  • Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 7 days ]


Original Secondary Outcome: Same as current

Information By: Ardelyx

Dates:
Date Received: January 10, 2017
Date Started: January 2017
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017