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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03018067

Enrollment

Registered

2017-01-11

Start date

2017-01-31

Completion date

2017-05-31

Last updated

2019-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 description

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

Interventions

DRUGRDX227675

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Exponential Rate of Change in Serum Potassium from Baseline	48 hours	Onset of Action

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026