Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors

Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors: randomized controlled clinical trial "CANREO-PMO" - CANREO-PMO

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003285-40-FR

Enrollment

Registered

2020-07-20

Start date

2020-12-15

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemodynamic of patients in a state of cerebral death candidate for renal or multiple organ removal (including kidney) MedDRA version: 21.0 Level: PT Classification code 10058985 Term: Organ donor System Organ Class: 10041244 - Social circumstances

Interventions

Trade Name: SOLUDACTONE 200 mg Product Name: Soludactone 200mg Pharmaceutical Form: Lyophilisate and solvent for solution for injection INN or Proposed INN: POTASSIUM CANRENOATE CAS Number: 2181-04-6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Men, women aged 18 years or older; • Encephalic death diagnosed either by 2 flat and areactive 30-minute electroencephalograms performed 4 hours apart or by a cerebral CT angiography showing a non-opacification of the cortical middle cerebral arteries and internal cerebral veins; • And from whom an harvesting of one or both kidneys is envisaged (within 6 hours or more), according to the procedures currently in force at the Agence de la Biomédecine; • Dose of vasopressor agent that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor pressure less than 7 mg / h at inclusion; • Euvolemic patient at inclusion; • Affiliated to Social Security scheme; • Signed written consent by the support person provided for in article L. 1111-6, or failing this by a family member. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: • Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study; • Patient on long-term mineralocorticoid receptor antagonist (eplerenone or spironolactone); • Having a serum potassium concentration> 5.5 mmol / L on inclusion; • Contraindications to multi-organ removal (infectious, neoplastic causes, etc.); • Refusal of organ removal expressed by the patient (national register of refusals or reported by the family); • Probable inability to remove the kidneys: history of urine-renal disease, pre-existing chronic renal failure, morphological abnormalities of the kidneys, renal trauma; • Patients included in another interventional drug clinical trial; • Known potassium canrenoate and / or trometamol hypersensitivity; • Severe renal failure; • Severe atrioventricular conduction disorders; • Terminal stage of hepatocellular insufficiency; • Persons referred to in articles L. 1121-5, L.1121-6, L. 1121-7 and L1121-8 of France’s public health code: -Pregnant, parturient or lactating woman; -Persons deprived of their liberty by a judicial or administrative decision; -Minors (non emancipated); -Adults subject to legal protection measures (guardianship, curatorship, safeguard of justice); -Person undergoing psychiatric care under articles L3212-1 and L3213-1 of the Public Health Code.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the impact of potassium canrenoate administration vs. placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting (including renal).;Secondary Objective: Assess the impact of potassium canrenoate administration vs. placebo in brain-dead donor on: 1. the function of the graft at 3 months after transplantation in kidney recipients from these donors, 2. the presence of dialysis or a glomerular filtration rate (GFR) estimated according to CKD-EPI <20mL / min / 1.73m2 at 3 months in kidney recipients from these donors, 3. the survival of kidney recipients from these donors evaluated at 3 months, 4. renal function, graft survival, and survival of kidney recipients from these donors evaluated at 1 year, 3 years and 10 years after transplantation. ;Primary end point(s): The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) and used recently by our team in a trial in the context of resuscitation (Lévy, JACC, 2018 - PMID 29976291) including in descending order: A. death before organ removal, B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ), C. the average hourly dose of noradrenaline / adrenaline between randomisation and departure to the operating room, D. the average hourly volume of crystalloids and / or colloids used between randomization and departure to the operating room. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) and used recently by our team in a trial in the context of resuscitation (Lévy, JACC, 2018 - PMID 29976291) including in descending order: A. death before organ removal, B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ), C. the av	—

Measure

Time frame

Main Objective: To assess the impact of potassium canrenoate administration vs. placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting (including renal).;Secondary Objective: Assess the impact of potassium canrenoate administration vs. placebo in brain-dead donor on: 1. the function of the graft at 3 months after transplantation in kidney recipients from these donors, 2. the presence of dialysis or a glomerular filtration rate (GFR) estimated according to CKD-EPI <20mL / min / 1.73m2 at 3 months in kidney recipients from these donors, 3. the survival of kidney recipients from these donors evaluated at 3 months, 4. renal function, graft survival, and survival of kidney recipients from these donors evaluated at 1 year, 3 years and 10 years after transplantation. ;Primary end point(s): The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) and used recently by our team in a trial in the context of resuscitation (Lévy, JACC, 2018 - PMID 29976291) including in descending order: A. death before organ removal, B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ), C. the average hourly dose of noradrenaline / adrenaline between randomisation and departure to the operating room, D. the average hourly volume of crystalloids and / or colloids used between randomization and departure to the operating room. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) and used recently by our team in a trial in the context of resuscitation (Lévy, JACC, 2018 - PMID 29976291) including in descending order: A. death before organ removal, B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ), C. the av

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Secondary

Measure	Time frame
Secondary end point(s): Secondary objectifs will be evaluated by consulting data from the CRISTAL database : Objective 1 : the vital status and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant, Objective 2 : the percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months, Objective 3 : the vital status of kidney recipients from these donors at 3 months Objective 4 : the vital status of kidney recipients from these donors and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant. ;Timepoint(s) of evaluation of this end point: Objective 1 : the vital status and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant, Objective 2 : the percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months, Objective 3 : the vital status of kidney recipients from these donors at 3 months Objective 4 : the vital status of kidney recipients from these donors and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant.	—

Measure

Time frame

Secondary end point(s): Secondary objectifs will be evaluated by consulting data from the CRISTAL database : Objective 1 : the vital status and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant, Objective 2 : the percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months, Objective 3 : the vital status of kidney recipients from these donors at 3 months Objective 4 : the vital status of kidney recipients from these donors and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant. ;Timepoint(s) of evaluation of this end point: Objective 1 : the vital status and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant, Objective 2 : the percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months, Objective 3 : the vital status of kidney recipients from these donors at 3 months Objective 4 : the vital status of kidney recipients from these donors and serum creatinine (in µmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant.

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Countries

France

Contacts

Public ContactDirector of Research and Innovation

CHRU de Nancy

dripromoteur@chru-nancy.fr+3383155285

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026