A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 1/12/2017 |
Start Date: | January 2017 |
Contact: | David P Rosenbaum, Ph.D. |
Email: | drosenbaum@ardelyx.com |
A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
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).
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).
The study consists of a screening visit, a 7-day treatment period, and a 7-day
treatment-free follow-up period.
treatment-free follow-up period.
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
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