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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
Sponsor:
Information provided by (Responsible Party):
Alp Sener, Lawson Health Research Institute

Brief Summary:
Kidneys retrieved from deceased donors will be randomized for conventional perfusion (University of Wisconsin: UW) with or without supplementation of thiosulfate, a major H2S metabolite, and transpl anted thereafter. Recipient's renal function will be assessed prospectively to determine if thiosulfate improves allograft function.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Drug: Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25% Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Patient urine output [ Time Frame: 1 week ]
    1 week following transplant

  2. Change in Patient urine output [ Time Frame: 1 year ]
    between 1 week and 1 year following transplant

  3. Serum Creatinine [ Time Frame: 1 week after transplant ]
    Patient Blood serum creatinine results

  4. Slow Graft Function [ Time Frame: 1 week after transplant ]
    Patients' Rate of slow graft function

  5. eGFR [ Time Frame: 1 week after transplant ]
    Patient eGFR Results


Secondary Outcome Measures :
  1. Biopsy proven Acute tubular necrosis (ATN) [ Time Frame: 1 week ]
    Measuring death of tubular epithelial cells that form the renal tubules of the kidneys.

  2. Urine protein/creatinine ratio [ Time Frame: 1 week ]
    Patient Urine protein/creatinine ratio results

  3. Urinary injury biomarkers (KIM-1/NGAL). [ Time Frame: 1 week ]
    Patient urinary injury biomarkers (KIM-1/NGAL).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All patients >18years old who are being considered for renal transplantation at LHSC that are receiving a DCD kidney.

Exclusion Criteria:

  • Age <18 years old
  • Inability to give informed consent,
  • Patients receiving kidneys from living donors
  • Patients with known hypersensitivity to either SEACALPHYX or to any of the ingredients contained within.
  • Pregnant women.
  • Patients with sulfite allergies

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Alp Sener, Dr. LHSC
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Responsible Party: Alp Sener, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04292184    
Other Study ID Numbers: 112145
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents