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NCT Number: NCT07051447

The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial

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).

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Key information

Conditions

End Stage Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PKRxHD

Other

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).

Dialysis

Procedure

Standard of care dialysis.

Primary outcomes

  1. 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.

  2. Recruitment Feasibility

    Time frame: Baseline

    Measured as the proportion of eligible patients enrolled successfully.

  3. Incidence Rate of Pre-HD Hyperkalemia

    Time frame: Baseline

    Hyperkalemia is defined as K≥ 6.4 mEq/L.

  4. Post-HD Recovery Time

    Time frame: Up to Week 24

    Measured as the average time to recovery following each HD session.

Secondary outcomes

  1. Incidence Rate of Post-HD Hyperkalemia Incidence Rate

    Time frame: Up to Week 24

    Hyperkalemia is defined as K≥ 6.4 mEq/L.

  2. Incidence Rate of Moderate Hyperkalemia

    Time frame: Up to Week 24

    Hyperkalemia is defined as K≥ 3.0 mEq/L.

  3. Incidence Rate of Peri-Dialytic Cramping

    Time frame: Up to Week 24

  4. Incidence Rate of Intradialytic Hypotension

    Time frame: Up to Week 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Charytan, MD

CONTACT

[email protected]

212-263-0705

Zoe Rimler

CONTACT

[email protected]

212-263-2544

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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.

Acronym: RADAR-K

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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