Hyperkalemia Clinical Trial
Official title:
A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Verified date | December 2019 |
Source | Ardelyx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 60 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Capital Nephrology Associates, PA | Cary | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Ardelyx |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exponential Rate of Change in Serum Potassium from Baseline | Onset of Action | 48 hours | |
Secondary | Change in Serum Potassium Levels | 7 days | ||
Secondary | Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] | 7 days |
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