| Trial ID: | L0703 |
| Source ID: | NCT04292184
|
| Associated Drug: |
Seacalphyx (Sodium Thiosulfate Pentahydrate Injection Bp) 25%
|
| Title: |
Evaluation of Thiosulfate in End Stage Renal Disease and Kidney Transplantation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%
|
| Outcome Measures: |
Primary: Patient urine output, 1 week following transplant, 1 week|Change in Patient urine output, between 1 week and 1 year following transplant, 1 year|Serum Creatinine, Patient Blood serum creatinine results, 1 week after transplant|Slow Graft Function, Patients' Rate of slow graft function, 1 week after transplant|eGFR, Patient eGFR Results, 1 week after transplant | Secondary: Biopsy proven Acute tubular necrosis (ATN), Measuring death of tubular epithelial cells that form the renal tubules of the kidneys., 1 week|Urine protein/creatinine ratio, Patient Urine protein/creatinine ratio results, 1 week|Urinary injury biomarkers (KIM-1/NGAL)., Patient urinary injury biomarkers (KIM-1/NGAL)., 1 week
|
| Sponsor/Collaborators: |
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-21
|
| Completion Date: |
2022-11-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-12-12
|
| Locations: |
London Health Sciences Centre, University Hospital, London, Ontario, N6A 5A5, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT04292184
|
