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

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx

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