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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03018067
Other study ID # RDX227675-201
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 2017
Est. completion date May 2017

Study information

Verified date December 2019
Source Ardelyx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RDX227675

Placebo


Locations

Country Name City State
United States Capital Nephrology Associates, PA Cary North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exponential Rate of Change in Serum Potassium from Baseline Onset of Action 48 hours
Secondary Change in Serum Potassium Levels 7 days
Secondary Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] 7 days
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