An interventional study of PKRxHD and Dialysis in End Stage Kidney Disease, sponsored by NYU Langone Health. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Other
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).
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
This study's planned enrollment of 120 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a novel dialysate potassium (K) management strategy.
Other: PKRxHD · Procedure: Dialysis
Standard dialysis potassium prescribing.
Procedure: Dialysis
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.
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.
Time frame: Up to Week 24
Recruitment Feasibility
Measured as the proportion of eligible patients enrolled successfully.
Time frame: Baseline
Incidence Rate of Pre-HD Hyperkalemia
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Time frame: Baseline
Post-HD Recovery Time
Measured as the average time to recovery following each HD session.
Time frame: Up to Week 24
Incidence Rate of Post-HD Hyperkalemia Incidence Rate
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Time frame: Up to Week 24
Incidence Rate of Moderate Hyperkalemia
Hyperkalemia is defined as K≥ 3.0 mEq/L.
Time frame: Up to Week 24
Incidence Rate of Peri-Dialytic Cramping
Time frame: 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.
Time frame: Up to Week 24
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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NYU Langone Health