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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03018067
Recruitment Status : Terminated (Sponsor stopped program])
First Posted : January 11, 2017
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Brief 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).

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: RDX227675 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Drug: Placebo
Experimental: 10 g qd
RDX227675, 10 g qd
Drug: RDX227675
Experimental: 20 g qd
RDX227675, 20 g qd
Drug: RDX227675
Experimental: 30 g qd
RDX227675, 30 g qd
Drug: RDX227675



Primary Outcome Measures :
  1. Exponential Rate of Change in Serum Potassium from Baseline [ Time Frame: 48 hours ]
    Onset of Action


Secondary Outcome Measures :
  1. Change in Serum Potassium Levels [ Time Frame: 7 days ]
  2. Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018067


Locations
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United States, North Carolina
Capital Nephrology Associates, PA
Cary, North Carolina, United States, 27511
Sponsors and Collaborators
Ardelyx
Investigators
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Study Chair: David P Rosenbaum, Ph.D. Ardelyx, Inc.
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Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT03018067    
Other Study ID Numbers: RDX227675-201
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases