A Study Evaluating the Onset-of-Action, Safety, and Effic... | NCT03018067

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

NCT03018067

Sponsor

Ardelyx

Status

Terminated

Last Update Posted

Dec 26, 2019Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Hyperkalemia

Interventions

RDX227675
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor stopped program]

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 10, 2017

First Posted Date

Jan 11, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2019

Last Update Posted Date

Dec 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	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
10 g qd	Experimental	RDX227675, 10 g qd	Drug: RDX227675
20 g qd	Experimental	RDX227675, 20 g qd	Drug: RDX227675
30 g qd	Experimental	RDX227675, 30 g qd	Drug: RDX227675

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RDX227675	Drug		10 g qd 20 g qd 30 g qd
Placebo

Measure	Description	Time Frame
Exponential Rate of Change in Serum Potassium from Baseline	Onset of Action	48 hours

Measure	Description	Time Frame
Change in Serum Potassium Levels		7 days
Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability]		7 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases