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

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).

Study Overview

• Status: Terminated
• Conditions: Hyperkalemia
• Intervention / Treatment: Drug: Placebo; Drug: RDX227675

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Capital Nephrology Associates, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Microcrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day.	Drug: Placebo
EXPERIMENTAL: 10 g qd; RDX227675, 10 g qd	Drug: RDX227675
EXPERIMENTAL: 20 g qd; RDX227675, 20 g qd	Drug: RDX227675
EXPERIMENTAL: 30 g qd; RDX227675, 30 g qd	Drug: RDX227675

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ardelyx

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (ESTIMATE): January 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyperkalemia
• Other Study ID Numbers: RDX227675-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO