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The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients.

Study acronym: EVATRAN
StatusRecruiting
PhasePhase 3
Started
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Record status
This record was last updated February 12, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Lead sponsor: Pr. Nicolas GIRERD to Central Hospital, Nancy, France
    • Primary and study completion dates: Mar 2026 to Nov 2025
    v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Primary and study completion dates: Feb 2024 to Mar 2026v5
  4. Notable Lead sponsor: Central Hospital, Nancy, France to Pr. Nicolas GIRERDv4 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2023 to Feb 2024
    • Start date changed from estimate of Feb 2021 to Oct 12, 2021
    • Site details revised
  5. Notable Start date: Nov 2020 to Feb 2021
    • Primary completion date: Apr 2023 to Jul 2023
    • Study completion date: Apr 2024 to Jul 2023
    v3
  6. Notable Start date: Sep 2020 to Nov 2020v2 Show 4 more changesShow less
    • Primary completion date: Feb 2023 to Apr 2023
    • Study completion date: Feb 2024 to Apr 2024
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (21)
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cardiovascular (CV) pathologies are the leading cause of death in kidney transplant patients.Arterial stiffness is a prognostic factor for CV mortality in kidney transplantation. Despite a reduced CV risk in transplant kidney patients in comparison to patients in dialysis, CV mortality among kidney transplant patients is much higher than the general population. After renal transplantation, the cardiac and vascular anomalies observed in chronic end-stage renal disease are partially improved because of restored normal kidney function and withdrawal from dialysis. However, patients are exposed to immunosuppressive drugs, in particular calcineurin inhibitors, which can be associated with vascular toxicity, either directly or by promoting the appearance of hypertension, diabetes, or dyslipidemia.The pathophysiology of arterial stiffness in kidney transplantation is complex and multifactorial. Calcineurin inhibitors are likely to play an important role in the persistence of increased arterial stiffness in transplant patients in whom renal function has been restored. Indeed, the discontinuation of anti-calcineurins in favour of other molecules .is associated with a decrease of arterial stiffness. Preclinical work has shown that the vascular toxicity of cyclosporine is mediated by activation of the mineralocorticoid receptor in smooth muscle cells. The involvement of the mineralocorticoid receptor in the onset of arterial stiffness is also well demonstrated in non-transplanted subjects. Blocking the mineralocorticoid receptor in patients under cyclosporine may reduce their arterial stiffness and in and consequently improve their CV prognosis. Studies have show a good safety in kidney transplant patients. This pilot study proposes to examine, for the first time, the impact of treatment with a mineralocorticoid receptor antagonist on the evolution of arterial stiffness in renal transplant patients on calcineurin inhibitors.
Trial Details
NCT Number NCT04450953
Lead Sponsor Central Hospital, Nancy, France
Conditions
(from sponsor)
Kidney Transplantation for More Than One Year, Patients with a Kidney Transplantation on Cyclosporine
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov