NCT03018067

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.

Conditions

• Hyperkalemia

Interventions

Type	Name	Description
DRUG	RDX227675
DRUG	Placebo

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2017-01-11
• Last updated: 2019-12-26

Locations

1 site across 1 country: United States