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

NCT ID: NCT07051447

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2029-08-01

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).

Conditions

End Stage Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Precision approach to K Prescription for HD (PKRxHD)

Participants will receive a novel dialysate potassium (K) management strategy.

Group Type: EXPERIMENTAL

PKRxHD

Intervention Type: 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

Intervention Type: PROCEDURE

Standard of care dialysis.

Usual Care

Standard dialysis potassium prescribing.

Group Type: ACTIVE_COMPARATOR

Dialysis

Intervention Type: PROCEDURE

Standard of care dialysis.

Interventions

PKRxHD

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).

Intervention Type: OTHER

Dialysis

Standard of care dialysis.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

David Charytan, MD

Role: CONTACT

David.Charytan@nyulangone.org

212-263-0705

Zoe Rimler

Role: CONTACT

Zoe.Rimler@nyulangone.org

212-263-2544

Other Identifiers

24-01766

Identifier Type: -

Identifier Source: org_study_id