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A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT03018067•Ardelyx

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 85 years old, inclusive
•Two consecutive i-STAT K values ≥ 5.5 to \< 6.5 mmol/L, measured a minimum of 60-minutes apart within 1 day of first RDX227675 dose on Day 1 (prior to randomization)
•i-STAT K value ≥ 5.5 to \< 6.5 mmol/L on Day 1 (prior to randomization)
•Ability to have repeated blood draws or effective venous catheterization
•Females of child bearing potential must have negative urine pregnancy test on Day 1 (prior to randomization)
•Females but be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
•Males must agree to use an appropriate method of contraception or have documented surgical sterilization

Exclusion Criteria

•Pseudohyperkalemia signs and symptoms
•Treatment with K lowering drugs, within 7 days prior to randomization
•Uncontrolled Type 2 diabetes, as defined as most recent historical HbA1c \> 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
•Diabetic ketoacidosis
•Known hypersensitivity to polystyrene sulfonate
•Significant cardiovascular or cerebrovascular events in the past 2 months
•Severe heart failure, defined as NYHA (New York Heart Association) class IV or hospitalization to treat heart failure in previous 3 months
•History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, or major gastrointestinal surgery
•Major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 3 years. History of attempted suicide or uncontrolled bipolar disorder.
•Use of an investigational product within 30 days prior to Screening

Locations (1)

Capital Nephrology Associates, PA

Cary, North Carolina, United States

Key Dates

Start Date

January 1, 2017

Primary Completion Date

May 1, 2017

Completion Date

May 1, 2017

Last Updated

December 26, 2019

Enrollment

ESTIMATED participants

Conditions

Hyperkalemia

Interventions

RDX227675

DRUG

Placebo

DRUG

Hyperkalemia Quality Improvement Program (HK-QIP) Study

NCT06884267

Hyperkalemia

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RECRUITINGPHASE1/PHASE2

Adding Urea to the Final Dialysis Fluid

NCT06366230

Dysequilibrium SyndromeESRD+2 more

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COMPLETEDPHASE4

Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Hyperkalemia Quality Improvement Program (HK-QIP) Study

Adding Urea to the Final Dialysis Fluid

Patiromer Efficacy to Reduce Episodic Hyperkalemia in End Stage Renal Disease Patients

The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

Dietary Fiber and Hyperkalemia in Dialysis Patients

Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients