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Trial record 2 of 2 for:    ardelyx | Hyperkalemia | United States

A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia (Redukx)

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: NCT04780841
Recruitment Status : Completed
First Posted : March 4, 2021
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
Ardelyx

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

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: RDX013 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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
Masking: Single (Participant)
Masking Description: 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)
Primary Purpose: Treatment
Official Title: A Two-Part Proof-of-Concept Study: An Open-Label Dose-Ranging Phase (Part A) Followed by a Randomized, Single-Blind, Placebo-Controlled Phase (Part B) Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
Actual Study Start Date : January 11, 2021
Actual Primary Completion Date : December 28, 2021
Actual Study Completion Date : March 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: RDX013 Cohort 1
RDX013 low dose oral dosage, twice daily
Drug: RDX013
RDX013 is an experimental drug that is a potassium secretagogue

Experimental: RDX013 Cohort 2
RDX013 low, mid dose oral dosage, twice daily
Drug: RDX013
RDX013 is an experimental drug that is a potassium secretagogue

Experimental: RDX013 Cohort 3
RDX013 high, mid dose oral dosage, twice daily
Drug: RDX013
RDX013 is an experimental drug that is a potassium secretagogue

Experimental: RDX013 Cohort 4
RDX013 high dose oral dosage, twice daily
Drug: RDX013
RDX013 is an experimental drug that is a potassium secretagogue

Experimental: RDX013 Part B
RDX013 dose from Part A oral dosage, twice daily
Drug: RDX013
RDX013 is an experimental drug that is a potassium secretagogue

Placebo Comparator: Placebo Part B
oral dosage, twice daily
Drug: Placebo
Placebo treatment that looks identical to experimental treatment




Primary Outcome Measures :
  1. Change in serum potassium; Part A [ Time Frame: 1 week ]
    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.

  2. Change in serum potassium; Part B [ Time Frame: 4 weeks ]
    To evaluate the difference between RDX013 and placebo in the change of serum potassium from baseline to the end of treatment.


Secondary Outcome Measures :
  1. Exporatory Objective; time to serum potassium normalization [ Time Frame: 4 weeks ]
    To evaluate the time to initial normalization of serum potassium level (≥3.5 to ≤5.0 mmol/L) during the initial 24 hours of treatment.



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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:

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

Exclusion Criteria:

  1. Pseudo-hyperkalemia signs and symptoms
  2. Treatment with potassium-lowering drugs within 7 days prior to enrollment/randomization
  3. Treatment with glucocorticoids
  4. Uncontrolled Type 2 diabetes, defined as most recent historical HbA1c > 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
  5. Diabetic ketoacidosis
  6. Severe heart failure, defined as NYHA (New York Heart Association) Class IV or hospitalization to treat heart failure in previous 3 months
  7. History of bowel obstruction, severe gastrointestinal disorders, or major gastrointestinal surgery (e.g., large bowel resection)
  8. Females who are pregnant, lactating, or not willing to use appropriate contraception

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): NCT04780841


Locations
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United States, Florida
Horizon Research Group LLC
Coral Gables, Florida, United States, 33134
Panax Clinical Research LLC
Miami Lakes, Florida, United States, 33014
South Florida Research Phase I-IV; Inc.
Miami Springs, Florida, United States, 33166
United States, Louisiana
NW Louisiana Nephrology Assoc
Shreveport, Louisiana, United States, 71101
United States, Missouri
Clinical Research Consultants
Kansas City, Missouri, United States, 64111
United States, North Carolina
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
Ardelyx
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Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT04780841    
Other Study ID Numbers: RDX013-201
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases