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Urea in Dialysis Fluid for Renal Disease

Phase 1 & 2
Waitlist Available
Led By Ramin Sam, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up potassium levels every 6 hours for 24 hours after end of dialysis
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find a way to effectively treat patients with advanced renal failure who have high levels of potassium or acidosis. By adding urea to the dialysis fluid, the aim is to prevent

Who is the study for?
This trial is for patients with advanced kidney failure who have dangerously high levels of potassium or severe acidosis, and very high blood urea nitrogen (BUN) levels. It's not suitable for those who might experience a rapid drop in BUN leading to disequilibrium syndrome.
What is being tested?
The study tests adding urea to the dialysis fluid. This could help manage serum BUN levels while aggressively treating high potassium or acidosis without risking disequilibrium syndrome during dialysis.
What are the potential side effects?
Potential side effects may include discomfort at the site where dialysis is performed, imbalances in electrolytes, headache, nausea, and muscle cramps due to changes in blood chemistry.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours after starting dialysis
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours after starting dialysis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disequilibrium
Serum CO2 concentration
Serum potassium concentration
Secondary study objectives
Serum BUN concentration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Urea dialysateExperimental Treatment1 Intervention
Patients who had urea added to the final dialysis fluid

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,930 Total Patients Enrolled
Ramin Sam, MDPrincipal InvestigatorZuckerberg San Francisco General- UCSF
~13 spots leftby Jun 2028
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