120 Participants NeededMy employer runs this trial

Sodium Thiosulfate for Kidney Transplant

CB
Overseen ByCadence Baker
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Alp Sener
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve outcomes for kidney transplants from deceased donors. Researchers are testing whether adding sodium thiosulfate, a compound that may protect kidneys, to the preservation process helps maintain kidney function after transplant. Participants will receive either standard care or the new treatment with sodium thiosulfate. The trial seeks individuals with end-stage renal disease receiving a kidney from a deceased donor. Researchers will follow participants for one year to assess the transplanted kidney's function. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance kidney transplant success rates.

What prior data suggests that sodium thiosulfate is safe for kidney transplantation?

Previous studies have shown that sodium thiosulfate (STS) has potential for protecting the kidneys. Research indicates that STS can improve kidney function by reducing damage in animal studies. Some studies also suggest that STS can protect kidney cells from damage caused by low oxygen levels.

STS is already used for other conditions, such as preventing kidney damage from certain chemotherapy treatments. A large study on STS for a different condition found that most patients did not experience severe side effects, although some did encounter issues. This suggests STS is generally well-tolerated, but like any treatment, it may not work the same for everyone.

Overall, these findings suggest that STS might be safe and helpful for kidney transplants, but more research in humans is needed to confirm this.12345

Why are researchers excited about this trial?

Sodium Thiosulfate is unique because it offers a novel approach to kidney transplant care by potentially reducing the risk of calcification, which is a common issue post-transplant. Unlike standard treatments that primarily focus on immunosuppression to prevent rejection, Sodium Thiosulfate works differently by targeting calcium deposits, which can harm the transplanted kidney. Researchers are excited about this treatment because it addresses a specific problem that current options do not directly tackle, offering hope for improved long-term transplant outcomes.

What evidence suggests that sodium thiosulfate might be an effective treatment for kidney transplant?

Research has shown that sodium thiosulfate (STS), which participants in this trial may receive, can enhance the quality of kidneys used in transplants. In animal studies, adding STS to the organ preservation solution improved kidney function and extended survival for transplant recipients. STS reduces damage, cell death, and inflammation during the transplant process. These effects hold promise for improving kidney transplant outcomes, particularly with kidneys from deceased donors. STS has proven beneficial not only for kidney preservation but also in other medical treatments, highlighting its potential as a protective agent during transplants.14678

Who Is on the Research Team?

AS

Alp Sener

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

Inclusion Criteria

I am getting a kidney transplant from a deceased donor.
I have end-stage kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a kidney transplant with or without STS enhancement in the preservation solution

Immediate post-transplant period
1 visit (in-person)

Follow-up

Participants are monitored for graft function and survival, with blood and urine collection to determine graft function

12 months
Regular visits (frequency not specified)

Data Analysis

Data analysis to separate variables and design future trials

4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Sodium Thiosulfate

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alp Sener

Lead Sponsor

Trials
1
Recruited
120+

Citations

Effect of Sodium Thiosulfate Pre-Treatment on Renal Ischemia ...

The addition of sodium thiosulfate (STS) to organ preservation solution improved renal graft quality and prolonged recipient survival.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39273476/

Effect of Sodium Thiosulfate Pre-Treatment on Renal ...

Our results suggest that STS pre-treatment may improve renal graft function after transplantation. Keywords: University of Wisconsin (UW) ...

Intravenous Sodium Thiosulphate for Calciphylaxis of ...

In case reports and multi-case reports, the effective rates for STS treatment were 67% and 84.4%, respectively. ... Complete and partial wound ...

Evaluation of Thiosulfate Enhanced Organ Preservation ...

DCD kidneys have up to a 30% risk of graft loss at 5 years and up to 50% in 10 years [10-13]. Significant efforts have been applied to ...

Sodium Thiosulphate Not Much Help for Calciphylaxis in ...

Sodium thiosulphate treatment also didn't help reduce the risk of death in patients with CKD experiencing calciphylaxis in 15 studies looking at ...

Effect of Sodium Thiosulfate Pre-Treatment on Renal ...

In this study, we found that STS pre-treatment protected rat kidney epithelial cells against in vitro hypoxia–reoxygenation injury, and there was some evidence ...

Efficacy and Safety of Optimized Sodium Thiosulfate Therapy ...

The mean age was 51.10 ± 14.85 years old and 71% of patients were male. By October 2019, 87.1% of patients survived, 74.2% markedly improved and ...

Sodium Thiosulfate Reduces Acute Kidney Injury in Patients ...

The aim of this study is to evaluate the protective effect of perioperative sodium thiosulfate (STS) administration on kidney function in patients undergoing ...