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

NCT04714710 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-03

No results posted yet for this study

Summary

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.

Conditions

  • Brain-dead Organ Donors

Interventions

DRUG

IV Potassium Canrenoate

Administration of 200 mg of IV potassium canrenoate (diluted in sodium chloride 0.9%) in brain-dead donors within 10 hours after the diagnosis of brain death and before the departure to the operating room. Second administration of potassium canrenoate 6 hours after first administration if the patient is not YET admitted IN the operating room

DRUG

IV Sodium Chloride 0.9 %

Administration of IV sodium chloride 0.9% (placebo) in brain-dead donors within 10 hours after the diagnosis of brain death is made and before the departure to the operating room. Second administration of IV sodium chloride 0.9% (placebo) 6 hours after first administration if the patient is not YET admitted IN the operating room.

Sponsors & Collaborators

  • Pr. Nicolas GIRERD

    lead OTHER

Principal Investigators

  • Philippe GUERCI, MD, PhD · CHRU de NANCY

  • Nicolas GIRERD, MD-PhD · CHRU de NANCY

  • Patrick ROSSIGNOL, MD-PhD · CHRU de NANCY

  • Luc FRIMAT, MD-PhD · CHRU de NANCY

  • Hélène GREGOIRE, MD · CHRU de NANCY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2023-12-06
Completion
2033-12-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714710 on ClinicalTrials.gov