Urea in Dialysis Fluid for Renal Disease

Overseen By Ramin Sam, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Francisco

Disqualifiers: Pediatric, need for CRRT

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with advanced kidney problems requiring dialysis. The focus is on adding urea to the dialysis fluid, which may help manage severe issues like high potassium levels and acidosis (a condition with excess acid in the body). This approach could enable more aggressive dialysis without causing a dangerous drop in blood urea nitrogen levels. Suitable candidates have high serum urea levels and require dialysis due to high potassium or severe acidosis. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that adding urea to dialysis fluid is safe?

Research suggests that adding urea to dialysis fluid might help manage challenging conditions in kidney patients. However, direct safety information for using urea in this way remains limited. This treatment is in the early stages of clinical trials, as researchers study its safety for people.

Early clinical trials aim to understand how well people tolerate new treatments. Researchers closely monitor for any side effects or issues. Since urea naturally occurs in the body and aids kidney function, some experts believe it might be safe in controlled amounts. However, more research is needed to confirm this.

In summary, while adding urea to dialysis fluid could assist with difficult cases, its full safety is still under investigation. Participants in these trials help scientists learn more about the treatment's effectiveness and safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard dialysis treatments that primarily focus on removing waste products from the blood, this new approach involves adding urea directly into the dialysis fluid. Researchers are excited about using urea in dialysis because it could help stabilize the concentration of urea in the blood, potentially reducing the risk of complications related to rapid changes in blood chemistry. This method might offer a more balanced and gentle dialysis experience, providing better overall patient outcomes.

What evidence suggests that adding urea to dialysis fluid could be effective for renal disease?

Research has shown that adding urea to dialysis fluid might improve outcomes for patients with advanced kidney failure. In this trial, participants will receive dialysis with urea added to the final dialysis fluid. Studies indicate that better management of urea removal can lower the risk of disequilibrium syndrome—a condition where the body struggles to adjust to rapid changes in blood chemistry. Additionally, more effective urea removal during dialysis has been linked to lower mortality rates. This suggests that using urea could enhance dialysis effectiveness by removing harmful substances without causing rapid changes that might harm the patient. Overall, this approach aims to allow for more intensive dialysis to address issues like high potassium or acidosis without the usual risks. ^{1 3 6 7 8}

Who Is on the Research Team?

Ramin Sam, MD

Principal Investigator

Zuckerberg San Francisco General- UCSF

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I require dialysis.

Serum Urea > 120

My blood potassium is high, or my CO2 levels are low, or I need dialysis due to poisoning.

Exclusion Criteria

I require continuous renal replacement therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive dialysis with urea added to the final dialysis fluid to prevent disequilibrium syndrome

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

Monitoring every 6 hours for 24 hours, then twice a day for 3 days

What Are the Treatments Tested in This Trial?

Interventions

• Urea

Trial Overview 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.

How Is the Trial Designed?

Group I: Urea dialysate Experimental Treatment 1 Intervention

Patients who had urea added to the final dialysis fluid

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. withpower.com withpower.com/trial/urea-in-dialysis-fluid-for-renal-disease-3f55b

Urea in Dialysis Fluid for Renal Disease This implies that using urea in dialysis fluid might help optimize dialysis outcomes by better controlling urea removal.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6244854/

Assessment of dialysis adequacy: beyond urea kinetic ... In adults, even 1 ml/min/1.73m2 renal urea clearance is more beneficial than increasing Kt/V by dialysis [7] and is associated with approximately a 50% decrease ...

3. academic.oup.com academic.oup.com/ckj/article/17/7/sfae163/7687827

The impact of dialysate flow rate on haemodialysis adequacy A higher dialysate flow increased urea-based markers of dialysis adequacy. Additional high-quality research is needed to determine the clinical, ...

4. journalrip.com journalrip.com/PDF/jrip-12-e32132.pdf

Evaluation of hemodialysis adequacy using urea reduction ... Several studies illustrated that a rate of urea reduction rate (URR) of more than 65% can be an effective indicator of improving dialysis ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3116337/

Consequences of Frequent Hemodialysis - PubMed Central The data also indicated that the amount of urea removed during dialysis was related to mortality, with greater urea removal associated with lower mortality. A ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560513/

A prescription-based model for predicting post-hemodialysis ... A prescription-based model can reliably predict post-Hemodialysis urea and electrolyte values in urgent dialysis settings. The Adequator App HD- ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06366230

Adding Urea to the Final Dialysis Fluid 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 ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK441859/

Uremia - StatPearls - NCBI Bookshelf - NIH Urea and other uremic toxins, accumulated due to impaired renal clearance, are toxic to various tissues, especially the nervous system, leading to symptoms ...