A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
- Registration Number
- NCT03018067
- Lead Sponsor
- Ardelyx
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. 10 g qd RDX227675 RDX227675, 10 g qd 20 g qd RDX227675 RDX227675, 20 g qd 30 g qd RDX227675 RDX227675, 30 g qd
- Primary Outcome Measures
Name Time Method Exponential Rate of Change in Serum Potassium from Baseline 48 hours Onset of Action
- Secondary Outcome Measures
Name Time Method Change in Serum Potassium Levels 7 days Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] 7 days
Trial Locations
- Locations (1)
Capital Nephrology Associates, PA
🇺🇸Cary, North Carolina, United States