Evaluation of Thiosulfate in End Stage Renal Disease and Kidney Transplantation

NCT04292184 | Completed Phase 1 DMC

• 1 other identifier: 112145
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Biopsy proven Acute tubular necrosis (ATN)

  1 week

• Urine protein/creatinine ratio

  1 week

• Urinary injury biomarkers (KIM-1/NGAL).

  1 week

Study Arms (2)

UW (perfusion solution) + sodium thiosulfate (STS)

ACTIVE COMPARATOR

We will flush the deceased donor kidney with UW (perfusion solution) + sodium thiosulfate (STS)

Drug: Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%

UW (perfusion solution)

NO INTERVENTION

Kidney will be flushed with UW (perfusion solution) which is the normal standard of care.

Interventions

Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25% DRUG

The kidney will have 100 mL of 500µM STS added directly to the existing pulsatile perfusion solution at 4°C.

Also known as: Sodium thiosulfate (STS)

UW (perfusion solution) + sodium thiosulfate (STS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alp Sener, Dr.

  LHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: March 3, 2020
• Study Start: March 21, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CA (1)