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

Primary Purpose

Hyperkalemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RDX227675

Placebo

About this trial

This is an interventional treatment trial for Hyperkalemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Capital Nephrology Associates, PA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

10 g qd

20 g qd

30 g qd

Arm 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.

RDX227675, 10 g qd

RDX227675, 20 g qd

RDX227675, 30 g qd

Outcomes

Primary Outcome Measures

Exponential Rate of Change in Serum Potassium from Baseline

Onset of Action

Secondary Outcome Measures

Change in Serum Potassium Levels

Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]

Full Information

NCT ID

NCT03018067

First Posted

January 10, 2017

Last Updated

December 23, 2019

Sponsor

Ardelyx

1. Study Identification

Unique Protocol Identification Number

NCT03018067

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Why Stopped

Sponsor stopped program]

Study Start Date

January 2017 (Actual)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ardelyx

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperkalemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Arm Title

10 g qd

Arm Type

Experimental

Arm Description

RDX227675, 10 g qd

Arm Title

20 g qd

Arm Type

Experimental

Arm Description

RDX227675, 20 g qd

Arm Title

30 g qd

Arm Type

Experimental

Arm Description

RDX227675, 30 g qd

Intervention Type

Drug

Intervention Name(s)

RDX227675

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Exponential Rate of Change in Serum Potassium from Baseline

Description

Onset of Action

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Change in Serum Potassium Levels

Time Frame

7 days

Title

Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David P Rosenbaum, Ph.D.

Organizational Affiliation

Ardelyx, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Capital Nephrology Associates, PA

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27511

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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