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NCT06366230 · ClinicalTrials.gov registry record · Phase 1
Adding Urea to the Final Dialysis Fluid
A Phase 1 study of ESRD and Hyperkalemia, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06366230: Recruiting Phase 1 study of ESRD and Hyperkalemia, sponsored by University of California, San Francisco.
NCT06366230 is a Phase 1 study of ESRD and Hyperkalemia that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 139-participant average among 13 other ESRD trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06366230, a Phase 1 study of ESRD and Hyperkalemia, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.
Primary Outcome
Dialysis disequilibrium syndrome (DDS) refers to an array of neurological manifestations that are seen during or following dialysis. The symptoms can range from headache, nausea, blurred vision, restlessness and confusion to coma and seizures in rare cases. The physician will assess DDS.
Conditions Studied
Interventions
- DRUG Urea in the dialysate
Study Locations (1)
California
- Zuckerberg San Francisco General Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 1 |
What NCT06366230 shows while recruiting
NCT06366230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 139-participant average among 13 other ESRD trials with a reported enrollment target (86% lower).
The record links to 4 conditions, with ESRD appearing as the primary indexed condition, and to 1 intervention - of which Urea in the dialysate is the first listed.
NCT06366230 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06366230 about?
NCT06366230 is a clinical study titled "Adding Urea to the Final Dialysis Fluid". At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need ...
What is the current status of trial NCT06366230?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-09-16. Estimated completion is 2028-06-30.
What conditions does trial NCT06366230 study?
This clinical trial studies the following conditions: ESRD, Hyperkalemia, Metabolic Acidosis, Dysequilibrium Syndrome.
What interventions are being tested in trial NCT06366230?
The interventions under investigation include: Urea in the dialysate (DRUG).
Who is sponsoring clinical trial NCT06366230?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06366230 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ESRD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06366230's enrollment target sits among peer trials
20 13th of 13 higher than 1 of 13 other ESRD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ESRD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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