Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Adding urea to the final dialysis fluid

Official title: Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities

Run by University of California, San Francisco · NCT06366230 · Data updated 2026-11-12

This test tries adding urea to the dialysis fluid for adults with advanced kidney failure who have very high blood urea and need rapid lowering of potassium or correction of severe acidosis.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedSeptember 16, 2025
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedFebruary 12, 2026
Trial IDNCT06366230 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with end-stage renal disease who need dialysis and have serum urea >120 and either potassium >5.5, serum CO2 <15, or another urgent indication for aggressive dialysis, and who are not pediatric and do not require CRRT.

Probably not a fit

Pediatric patients, those requiring continuous renal replacement therapy, or patients with lower BUN or stable electrolytes are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional approach adds measured amounts of urea (using Ure-Na 15 g tablets) to the dialysate during hemodialysis so the dialysate urea concentration is kept about 15–40 mg/dL lower than the patient’s serum value. The calculation of how much urea to add is based on the dialysis system and the patient’s serum urea concentration. The aim is to allow aggressive removal of potassium and correction of metabolic acidosis while preventing a rapid drop in serum osmolality that can cause disequilibrium syndrome. Patients’ labs, vital signs, and symptoms are closely monitored throughout treatment to guide adjustments and safety assessments.

Why it matters

Potential benefit: If successful, this method could allow safe, rapid correction of life-threatening hyperkalemia or severe acidosis in patients with very high BUN while reducing the risk of dialysis disequilibrium.

How similar studies have gone: This specific tactic of adding urea to dialysate is relatively novel with limited published data, mainly theoretical discussion and small case-level reports rather than large trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Serum Urea \> 120
* Serum Potassium \> 5.5 or serum CO2 \< 15 or need for aggressive dialysis due to toxic ingestion
* need for dialysis

Exclusion Criteria:

* Pediatric
* need for CRRT

Where it's running

  • Zuckerberg San Francisco General Hospital
    San Francisco, California, United States
    Recruiting

Study contacts

  • Principal investigator: Ramin Sam, MD — Zuckerberg San Francisco General- UCSF
  • Study coordinator: Ramin Sam, MD
  • Email: ramin.sam@ucsf.edu
  • Phone: 6282066605

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.