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

NCT03018067 | Terminated Phase 2

• 1 other identifier: RDX227675-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (1)

• Exponential Rate of Change in Serum Potassium from Baseline

  Onset of Action

  48 hours

Secondary Outcomes (2)

• Change in Serum Potassium Levels

  7 days

• Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]

  7 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

10 g qd

EXPERIMENTAL

RDX227675, 10 g qd

Drug: RDX227675

20 g qd

EXPERIMENTAL

RDX227675, 20 g qd

Drug: RDX227675

30 g qd

EXPERIMENTAL

RDX227675, 30 g qd

Drug: RDX227675

Interventions

RDX227675 DRUG

10 g qd; 20 g qd; 30 g qd

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (1)

Capital Nephrology Associates, PA

Cary, North Carolina, 27511, United States

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David P Rosenbaum, Ph.D.

  Ardelyx, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)