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

Ardelyx

Status and phase

Terminated

Phase 2

Conditions

Hyperkalemia

Treatments

Drug: Placebo

Drug: RDX227675

Study type

Interventional

Funder types

Industry

Identifiers

NCT03018067

RDX227675-201

Details and patient eligibility

About

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).

Full description

The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

10 g qd

Experimental group

Description:

RDX227675, 10 g qd

Treatment:

Drug: RDX227675

20 g qd

Experimental group

Description:

RDX227675, 20 g qd