NCT04780841

Brief Summary

The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

January 26, 2021

Last Update Submit

May 3, 2022

Conditions

Hyperkalemia

Outcome Measures

Primary Outcomes (2)

  • Change in serum potassium; Part A

    To evaluate the change of serum potassium from baseline to the end of treatment with different doses of RDX013 to identify the optimal dose for further evaluation in Part B of the study.

    1 week

  • Change in serum potassium; Part B

    To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment.

    4 weeks

Secondary Outcomes (1)

  • Exporatory Objective; time to serum potassium normalization

    4 weeks

Study Arms (6)

RDX013 Cohort 1

EXPERIMENTAL

RDX013 low dose oral dosage, twice daily

Drug: RDX013

RDX013 Cohort 2

EXPERIMENTAL

RDX013 low, mid dose oral dosage, twice daily

Drug: RDX013

RDX013 Cohort 3

EXPERIMENTAL

RDX013 high, mid dose oral dosage, twice daily

Drug: RDX013

RDX013 Cohort 4

EXPERIMENTAL

RDX013 high dose oral dosage, twice daily

Drug: RDX013

RDX013 Part B

EXPERIMENTAL

RDX013 dose from Part A oral dosage, twice daily

Drug: RDX013

Placebo Part B

PLACEBO COMPARATOR

oral dosage, twice daily

Drug: Placebo

Interventions

RDX013DRUG

RDX013 is an experimental drug that is a potassium secretagogue

RDX013 Cohort 1RDX013 Cohort 2RDX013 Cohort 3RDX013 Cohort 4RDX013 Part B
PlaceboDRUG

Placebo treatment that looks identical to experimental treatment

Placebo Part B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged 18 to 85 years, inclusive
  • Serum potassium value 5.1 to \<6.5 mmol/L
  • Chronic kidney disease with eGFR ≥20 to \<60 mL/min/1.73m2
  • Able to understand and comply with the protocol
  • Willing and able to sign informed consent

You may not qualify if:

  • Pseudo-hyperkalemia signs and symptoms
  • Treatment with potassium-lowering drugs within 7 days prior to enrollment/randomization
  • Treatment with glucocorticoids
  • Uncontrolled Type 2 diabetes, defined as most recent historical HbA1c \> 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
  • Diabetic ketoacidosis
  • 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, severe gastrointestinal disorders, or major gastrointestinal surgery (e.g., large bowel resection)
  • Females who are pregnant, lactating, or not willing to use appropriate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Horizon Research Group LLC

Coral Gables, Florida, 33134, United States

Location

Panax Clinical Research LLC

Miami Lakes, Florida, 33014, United States

Location

South Florida Research Phase I-IV; Inc.

Miami Springs, Florida, 33166, United States

Location

NW Louisiana Nephrology Assoc

Shreveport, Louisiana, 71101, United States

Location

Clinical Research Consultants

Kansas City, Missouri, 64111, United States

Location

Mountain Kidney & Hypertension Associates

Asheville, North Carolina, 28801, United States

Location

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a two part study; Part A is open label and Part B is blinded to study participants (all drug labels for treatment arm and placebo will be identical)
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: In Part A, treatment arms will be dosed based on the results from the previous arm. For Part B, one treatment arm from Part A will be selected
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

March 4, 2021

Study Start

January 11, 2021

Primary Completion

December 28, 2021

Study Completion

March 3, 2022

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

US(6)