Clinical trial NCT03018067: A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Official title: A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hyperkalemia
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Exponential Rate of Change in Serum Potassium from Baseline
timeFrame: 48 hours
Secondary outcomes:
measure: Change in Serum Potassium Levels
timeFrame: 7 days
measure: Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]
timeFrame: 7 days
Other outcomes:
Locations:
city: Cary
country: United States
facility: Capital Nephrology Associates, PA
state: North Carolina
Study officials:
affiliation: Ardelyx, Inc.
name: David P Rosenbaum, Ph.D.
role: STUDY_CHAIR
References: