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Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial

Study acronym: CANREO-PMO
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Lead sponsor: Central Hospital, Nancy, France to Pr. Nicolas GIRERDv6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Feb 26, 2024 to Dec 6, 2023
    • Study completion date: Feb 26, 2025 to Dec 6, 2033
    • Site details revised
    v5
  4. Lead sponsor: Pr. Nicolas GIRERD to Central Hospital, Nancy, Francev4
  5. Primary endpoints revised (4)
    • Study description revised
    v3
  6. Lead sponsor: Central Hospital, Nancy, France to Pr. Nicolas GIRERDv2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 2023 to Feb 26, 2024
    • Study completion date: Nov 2024 to Feb 26, 2025
    • Start date changed from estimate of May 2021 to Aug 26, 2021
    • Site details revised
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Given the current organ shortage, improving the quality/efficacy of harvested grafts from expanded criteria donors is essential to substantially increase the number of potential donors. Preclinical studies have shown that blocking the vascular mineralocorticoid receptor (MR) mitigates ischemia-reperfusion injury (I/R) and prevents renal dysfunction following acute kidney injury. Potassium canrenoate is an intravenous MR antagonist. Blocking the MR upstream from aortic cross clamping is likely the most effective strategy to limit I/R injury. Yet, brain-dead donors are prone to severe hemodynamic instability and polyuria. Consequently, this study seeks to assess the hemodynamic tolerance of the use of potassium canrenoate in this context, as a first step to a large-scale clinical trial testing the impact of this therapeutic intervention on the survival of kidney grafts.
Trial Details
NCT Number NCT04714710
Lead Sponsor Pr. Nicolas GIRERD
Conditions
(from sponsor)		 Brain-dead Organ Donors
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov