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

• ClinicalTrials.gov Identifier: NCT03018067
• Recruitment Status: Terminated
• First Posted: January 11, 2017
• Last Update Posted: December 26, 2019
• Sponsor: Ardelyx
• Information provided by (Responsible Party): Ardelyx

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Hyperkalemia	Drug: RDX227675; Drug: Placebo	Phase 2

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: May 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Exponential Rate of Change in Serum Potassium from Baseline [ Time Frame: 48 hours ]
   Onset of Action

Secondary Outcome Measures :

1. Change in Serum Potassium Levels [ Time Frame: 7 days ]
2. Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 7 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Capital Nephrology Associates, PA

Cary, North Carolina, United States, 27511

Sponsors and Collaborators

Ardelyx

Investigators

• Study Chair: David P Rosenbaum, Ph.D.; Ardelyx, Inc.

More Information

• Responsible Party: Ardelyx
• ClinicalTrials.gov Identifier: NCT03018067
• Other Study ID Numbers: RDX227675-201
• First Posted: January 11, 2017
• Last Update Posted: December 26, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Hyperkalemia; Water-Electrolyte Imbalance; Metabolic Diseases