Adding Urea to the Final Dialysis Fluid

NCT06366230 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 24-41450
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysequilibrium Syndrome; ESRD; Hyperkalemia; Metabolic Acidosis

Keywords

ESRD; Urea; Disequilibrium; Potassium; Acid/base

Outcome Measures

Primary Outcomes (3)

• Disequilibrium

  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.

  within 24 hours after starting dialysis

• Serum potassium concentration

  Improvement in serum potassium concentration in mEq/L would be measured and documented with the study

  Potassium levels every 6 hours for 24 hours after end of dialysis

• Serum CO2 concentration

  Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L

  Serum CO2 levels every 6 hours for 24 hours after end of dialysis

Secondary Outcomes (1)

• Serum BUN concentration

  Serum BUN concentration twice a day for 3 days

Study Arms (1)

Urea dialysate

EXPERIMENTAL

Patients who had urea added to the final dialysis fluid

Drug: Urea in the dialysate

Interventions

Urea in the dialysate DRUG

Adding urea to the dialysis fluid. Ure-Na 15 grams would be used. It would be added to the acid component of the dialysis fluid. The amount added would depend on the serum BUN concentration and is determined by a simple calculation. It would be available in powder form. Urea would be added just to the first 1-3 dialysis treatments as needed.

Also known as: Ure-Na

Urea dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pediatric
• need for CRRT

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Dysequilibrium syndrome; Kidney Failure, Chronic; Hyperkalemia; Acidosis

Interventions

Urea

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Acid-Base Imbalance

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals

Study Officials

• Ramin Sam, MD

  Zuckerberg San Francisco General- UCSF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramin Sam, MD

CONTACT

6282066605; ramin.sam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 15, 2024
• Study Start: September 16, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)