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

NCT ID: NCT03018067

Last Updated: 2019-12-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-05-31

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.

Conditions

Hyperkalemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

10 g qd

RDX227675, 10 g qd

Group Type: EXPERIMENTAL

RDX227675

Intervention Type: DRUG

20 g qd

RDX227675, 20 g qd

Group Type: EXPERIMENTAL

RDX227675

Intervention Type: DRUG

30 g qd

RDX227675, 30 g qd

Group Type: EXPERIMENTAL

RDX227675

Intervention Type: DRUG

Interventions

RDX227675

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ardelyx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David P Rosenbaum, Ph.D.

Role: STUDY_CHAIR

Ardelyx, Inc.

Locations

Capital Nephrology Associates, PA

Cary, North Carolina, United States

Countries

United States

Other Identifiers

RDX227675-201

Identifier Type: -

Identifier Source: org_study_id