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

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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
Treatment:
Drug: RDX227675
30 g qd
Experimental group
Description:
RDX227675, 30 g qd
Treatment:
Drug: RDX227675

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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