The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial
RADAR-K
1 other identifier
interventional
120
0 countries
N/A
Brief 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 blood-dialysate K gradient minimization strategy (PKRxHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2025
CompletedFirst Posted
Study publicly available on registry
July 4, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
July 4, 2025
June 1, 2025
3.5 years
June 26, 2025
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Up to Week 24
Recruitment Feasibility
Measured as the proportion of eligible patients enrolled successfully.
Baseline
Incidence Rate of Pre-HD Hyperkalemia
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Baseline
Post-HD Recovery Time
Measured as the average time to recovery following each HD session.
Up to Week 24
Secondary Outcomes (4)
Incidence Rate of Post-HD Hyperkalemia Incidence Rate
Up to Week 24
Incidence Rate of Moderate Hyperkalemia
Up to Week 24
Incidence Rate of Peri-Dialytic Cramping
Up to Week 24
Incidence Rate of Intradialytic Hypotension
Up to Week 24
Study Arms (2)
Precision approach to K Prescription for HD (PKRxHD)
EXPERIMENTALParticipants will receive a novel dialysate potassium (K) management strategy.
Usual Care
ACTIVE COMPARATORStandard dialysis potassium prescribing.
Interventions
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).
Standard of care dialysis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2025
First Posted
July 4, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
July 4, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.