End Stage Kidney DiseaseRADAR-KNCT07051447
The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial
A study testing PKRxHD and Dialysis in people with End Stage Kidney Disease, run by NYU Langone Health.
Trial summary
This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- PKRxHD and Dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing in-center, 3x/weekly HD for treatment of end-stage kidney disease (ESKD) for at least 90 days
- Age at least 21 years
- Prescribed HD time up to 15 hours/ week
Who cannot join
- Incarcerated
- Life expectancy of 1 year or less
- Kidney transplant, transition to home dialysis, or transfer to non-participating HD unit anticipated within 6 months or less
- Cognitive condition that precludes consent
- Severe anemia (hemoglobin < 8.0 g/dL) within 30 days
- K concentration of 7.0 mEq/L or more within 60 days
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- Pregnant women
- Women of childbearing potential actively trying to conceive unwilling to use contraception
- Participation in other interventional studies within 30 days prior to enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial (RADAR-K): A Randomized, Controlled, Pilot Trial Comparing Usual Care to a Precision Approach to Dialysis Potassium Prescribing.
This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
- Conditions
- End Stage Kidney Disease
- Being tested
- PKRxHD, Dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PKRxHDOther
The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
DialysisProcedure or surgery
Standard of care dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Precision approach to K Prescription for HD (PKRxHD) | Experimental | Participants will receive a novel dialysate potassium (K) management strategy. Receives: Other: PKRxHD; Procedure: Dialysis |
| Usual Care | Active comparator | Standard dialysis potassium prescribing. Receives: Procedure: Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Adherence
Measured as the proportion of hemodialysis (HD) treatments in the experimental arm completed per protocol with both pre-HD point of care testing and appropriate adjustment of the dialysate prescription.
Measured: Up to Week 24
Recruitment Feasibility
Measured as the proportion of eligible patients enrolled successfully.
Measured: Baseline
Incidence Rate of Pre-HD Hyperkalemia
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Measured: Baseline
Post-HD Recovery Time
Measured as the average time to recovery following each HD session.
Measured: Up to Week 24
Secondary outcomes (4)
Incidence Rate of Post-HD Hyperkalemia Incidence Rate
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Measured: Up to Week 24
Incidence Rate of Moderate Hyperkalemia
Hyperkalemia is defined as K≥ 3.0 mEq/L.
Measured: Up to Week 24
Incidence Rate of Peri-Dialytic Cramping
Measured: Up to Week 24
Incidence Rate of Intradialytic Hypotension
Intradialytic hypotension will be defined as the proportion of HD sessions with intradialytic systolic blood pressure<90 mmHg, as this definition best captures associations with mortality according to current guidelines.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051447
- Sponsor's protocol ID
- 24-01766
- Acronym
- RADAR-K
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial (RADAR-K): A Randomized, Controlled, Pilot Trial Comparing Usual Care to a Precision Approach to Dialysis Potassium Prescribing.
- ClinicalTrials.gov ID
- NCT07051447
- Acronym / sponsor ID
- RADAR-K / 24-01766
- Conditions
- End Stage Kidney Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 4 Jul 2025 (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.
This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision approach to K Prescription for HD (PKRxHD) | Experimental | Other: PKRxHD, Procedure: DialysisParticipants will receive a novel dialysate potassium (K) management strategy. |
| Usual Care | Active comparator | Procedure: DialysisStandard dialysis potassium prescribing. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing in-center, 3x/weekly HD for treatment of end-stage kidney disease (ESKD) for at least 90 days
- Age at least 21 years
- Prescribed HD time up to 15 hours/ week
Key exclusion criteria (9 listed)
- Incarcerated
- Life expectancy of 1 year or less
- Kidney transplant, transition to home dialysis, or transfer to non-participating HD unit anticipated within 6 months or less
- Cognitive condition that precludes consent
- Severe anemia (hemoglobin < 8.0 g/dL) within 30 days
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 |
|---|---|---|
| PKRxHDThe precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD). | Other | Precision approach to K Prescription for HD (PKRxHD) |
| DialysisStandard of care dialysis. | Procedure or surgery | Precision approach to K Prescription for HD (PKRxHD), Usual Care |
Primary outcome
Intervention Adherence
Time frame: Up to Week 24
Measured as the proportion of hemodialysis (HD) treatments in the experimental arm completed per protocol with both pre-HD point of care testing and appropriate adjustment of the dialysate prescription.
Recruitment Feasibility
Time frame: Baseline
Measured as the proportion of eligible patients enrolled successfully.
Incidence Rate of Pre-HD Hyperkalemia
Time frame: Baseline
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Post-HD Recovery Time
Time frame: Up to Week 24
Measured as the average time to recovery following each HD session.
4 secondary outcomes
Incidence Rate of Post-HD Hyperkalemia Incidence Rate
Time frame: Up to Week 24
Incidence Rate of Moderate Hyperkalemia
Time frame: Up to Week 24
Incidence Rate of Peri-Dialytic Cramping
Time frame: Up to Week 24
Incidence Rate of Intradialytic Hypotension
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PKRxHD and Dialysis in people with End Stage Kidney Disease, run by NYU Langone Health.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Charytan, MD (212-263-0705, David.Charytan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Adherence (time frame: Up to Week 24). The study lists 4 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 Jul 2025.