HyperkalemiaPhase 2RedukxNCT04780841
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
A Phase 2 study testing RDX013 in people with Hyperkalemia, run by Ardelyx at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- RDX013
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Jan 2021to 3 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801
Horizon Research Group LLC
Coral Gables, Florida, 33134
Clinical Research Consultants
Kansas City, Missouri, 64111
Panax Clinical Research LLC
Miami Lakes, Florida, 33014
South Florida Research Phase I-IV; Inc.
Miami Springs, Florida, 33166
NW Louisiana Nephrology Assoc
Shreveport, Louisiana, 71101
About this study
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
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
- Conditions
- Hyperkalemia
- Being tested
- RDX013, Placebo
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDX013Drug
RDX013 is an experimental drug that is a potassium secretagogue
PlaceboDrug
Placebo treatment that looks identical to experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| RDX013 Cohort 1 | Experimental | RDX013 low dose oral dosage, twice daily Receives: Drug: RDX013 |
| RDX013 Cohort 2 | Experimental | RDX013 low, mid dose oral dosage, twice daily Receives: Drug: RDX013 |
| RDX013 Cohort 3 | Experimental | RDX013 high, mid dose oral dosage, twice daily Receives: Drug: RDX013 |
| RDX013 Cohort 4 | Experimental | RDX013 high dose oral dosage, twice daily Receives: Drug: RDX013 |
| RDX013 Part B | Experimental | RDX013 dose from Part A oral dosage, twice daily Receives: Drug: RDX013 |
| Placebo Part B | Placebo comparator | oral dosage, twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (1)
Exporatory Objective; time to serum potassium normalization
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start11 Jan 2021
- Primary completion28 Dec 2021
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780841
- Sponsor's protocol ID
- RDX013-201
- Acronym
- Redukx
- Status last verified
- May 2022
- First submitted
- 26 Jan 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04780841
- Acronym / sponsor ID
- Redukx / RDX013-201
- Conditions
- Hyperkalemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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
| Arm | Type | Receives |
|---|---|---|
| RDX013 Cohort 1 | Experimental | Drug: RDX013RDX013 low dose oral dosage, twice daily |
| RDX013 Cohort 2 | Experimental | Drug: RDX013RDX013 low, mid dose oral dosage, twice daily |
| RDX013 Cohort 3 | Experimental | Drug: RDX013RDX013 high, mid dose oral dosage, twice daily |
| RDX013 Cohort 4 | Experimental | Drug: RDX013RDX013 high dose oral dosage, twice daily |
| RDX013 Part B | Experimental | Drug: RDX013RDX013 dose from Part A oral dosage, twice daily |
| Placebo Part B | Placebo comparator | Drug: Placebooral dosage, twice daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDX013RDX013 is an experimental drug that is a potassium secretagogue | Drug | RDX013 Cohort 1, RDX013 Cohort 2, RDX013 Cohort 3, RDX013 Cohort 4, RDX013 Part B |
| PlaceboPlacebo treatment that looks identical to experimental treatment | Drug | Placebo Part B |
Primary outcome
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.
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.
1 secondary outcome
Exporatory Objective; time to serum potassium normalization
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
Related trials for Hyperkalemia
Enrolling by invitationObservational study
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A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
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Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
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Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDX013 in people with Hyperkalemia, run by Ardelyx at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum potassium; Part A (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.