Evaluation of Thiosulfate in End Stage Renal Disease and Kidney Transplantation
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|ClinicalTrials.gov Identifier: NCT04292184|
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2020
Last Update Posted : October 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease (ESRD)||Drug: Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||For the purposes of this study we will flush the deceased donor kidney with UW (perfusion solution) or UW + sodium thiosulfate (STS). There will be two groups in the study - UW with or without STS and patients will be randomly assigned to a group in a 1:1 ratio (i.e. 50 in one group and 50 in the other).|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Thiosulfate in End Stage Renal Disease and Kidney Transplantation|
|Actual Study Start Date :||March 21, 2021|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2023|
Active Comparator: UW (perfusion solution) + sodium thiosulfate (STS)
We will flush the deceased donor kidney with UW (perfusion solution) + sodium thiosulfate (STS)
Drug: Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%
The kidney will have 100 mL of 500µM STS added directly to the existing pulsatile perfusion solution at 4°C.
Other Name: Sodium thiosulfate (STS)
No Intervention: UW (perfusion solution)
Kidney will be flushed with UW (perfusion solution) which is the normal standard of care.
- Patient urine output [ Time Frame: 1 week ]1 week following transplant
- Change in Patient urine output [ Time Frame: 1 year ]between 1 week and 1 year following transplant
- Serum Creatinine [ Time Frame: 1 week after transplant ]Patient Blood serum creatinine results
- Slow Graft Function [ Time Frame: 1 week after transplant ]Patients' Rate of slow graft function
- eGFR [ Time Frame: 1 week after transplant ]Patient eGFR Results
- Biopsy proven Acute tubular necrosis (ATN) [ Time Frame: 1 week ]Measuring death of tubular epithelial cells that form the renal tubules of the kidneys.
- Urine protein/creatinine ratio [ Time Frame: 1 week ]Patient Urine protein/creatinine ratio results
- Urinary injury biomarkers (KIM-1/NGAL). [ Time Frame: 1 week ]Patient urinary injury biomarkers (KIM-1/NGAL).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292184
|London Health Sciences Centre, University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Alp Sener, Dr.||LHSC|