Brain-dead Organ DonorsPhase 2CANREO-PMONCT04714710
Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial
A Phase 2 study testing IV Potassium Canrenoate and IV Sodium Chloride 0.9 % in people with Brain-dead Organ Donors, run by Pr. Nicolas GIRERD at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain-dead Organ Donors
- What is being tested?
- IV Potassium Canrenoate and IV Sodium Chloride 0.9 %
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2021to 6 Dec 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 angioTDM objectifying a total cessation of intracranial circulation,
- And from whom a removal 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,
- Dosage of vasopressor agent amines that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor less than 7 mg / h at inclusion,
- euvolemic donor patient at inclusion,
- Benefiting from a Social Security affiliation scheme.
- Signature of consent by a family member or the support person.
Who cannot join
- 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,
Show all 16Show fewer
- Patients enrolled in another interventional drug trial,
- Person with a contraindication to potassium canrenoate and/or trometamol,
- Severe renal failure,
- Severe atrioventricular conduction disorders,
- Terminal stage of hepatocellular failure,
- 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 french Public Health Code
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Hemodynamic Tolerance of Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial
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.
Read the detailed description
In this single-center, double-blind, placebo-controlled clinical trial, we seek to evaluate the effect of the administration of 200 mg of IV potassium canrenoate vs placebo in brain-dead donors aged 18 years or more - within 10 hours after the diagnosis of brain death is made and before the departure to operating room.
The primary objective is 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).
The vital status and renal function of kidney recipients will be followed at 3 months, 1 year, 3 years and 10 years from transplant (main secondary objectives)
- Conditions
- Brain-dead Organ Donors
- Being tested
- IV Potassium Canrenoate, IV Sodium Chloride 0.9 %
- Keywords
- brain-dead organ donors, mineralocorticoid receptor, Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Potassium CanrenoateDrug
Also called Drug
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
IV Sodium Chloride 0.9 %Drug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Potassium canrenoate | Experimental | Potassium canrenoate 200mg diluted in SODIUM CHLORIDE SOLUTION 0.9% Receives: Drug: IV Potassium Canrenoate |
| Placebo (SODIUM CHLORIDE SOLUTION 0.9%) | Placebo comparator | SODIUM CHLORIDE SOLUTION 0.9% Receives: Drug: IV Sodium Chloride 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor death (cardio circulatory arrest)
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order:
- death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
Measured: from the randomization until the organ removal, up to 24 hours
Inability to perform kidney harvest
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order:
- death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
Measured: Up to 24 hours, in the organ removal during surgery
The average hourly dose of norepinephrine or epinephrine
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order:
- death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
Measured: From the randomization until the departure to the operating room, up to 24 hours
The average hourly volume of crystalloids and / or colloids
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order:
- death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
Measured: from the randomization until the departure to the operating room, up to 24 hours
Secondary outcomes (3)
Mortality rate of the kidney recipients
The number of patients dead after kidney transplantation
Measured: 3 months, 1 year, 3 years, and 10 years from kidney transplant
Serum creatinine (in μmol / L) of kidney recipients
With estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2).
Measured: 3 months, 1 year, 3 years, and 10 years from kidney transplant
Percentage of kidney recipients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m²
Number of patients on dialysis
Measured: 3 months after kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start26 Aug 2021
- Primary completion6 Dec 2023
- Study completion6 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain-dead Organ DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, double blinded randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr. Nicolas GIRERD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Philippe GUERCI, MD, PhD, Principal investigator, CHRU de NANCYNicolas GIRERD, MD-PhD, Study chair, CHRU de NANCYPatrick ROSSIGNOL, MD-PhD, Study chair, CHRU de NANCYLuc FRIMAT, MD-PhD, Study chair, CHRU de NANCYHélène GREGOIRE, MD, Study chair, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714710
- Sponsor's protocol ID
- 2020-003285-40
- Other IDs
- 2024-513809-31-00
- Acronym
- CANREO-PMO
- Status last verified
- Jun 2025
- First submitted
- 5 Jan 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reseanable request to the principal investigator in compliance with french regulations.
Publications
Belarif L, Girerd S, Jaisser F, Lepage X, Merckle L, Duarte K, Girerd N, Guerci P. Potassium canrenoate in brain-dead organ donors: a randomised controlled clinical trial protocol (CANREO-PMO). BMJ Open. 2023 Oct 11;13(10):e073831. doi: 10.1136/bmjopen-2023-073831.
PubMed 37821131
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamic Tolerance of Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04714710
- Acronym / sponsor ID
- CANREO-PMO / 2020-003285-40
- Conditions
- Brain-dead Organ Donors
- Keywords
- brain-dead organ donors, mineralocorticoid receptor, Kidney
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2033 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this single-center, double-blind, placebo-controlled clinical trial, we seek to evaluate the effect of the administration of 200 mg of IV potassium canrenoate vs placebo in brain-dead donors aged 18 years or more - within 10 hours after the diagnosis of brain death is made and before the departure to operating room.
The primary objective is 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).
The vital status and renal function of kidney recipients will be followed at 3 months, 1 year, 3 years and 10 years from transplant (main secondary objectives)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single center, double blinded randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Potassium canrenoate | Experimental | Drug: IV Potassium CanrenoatePotassium canrenoate 200mg diluted in SODIUM CHLORIDE SOLUTION 0.9% |
| Placebo (SODIUM CHLORIDE SOLUTION 0.9%) | Placebo comparator | Drug: IV Sodium Chloride 0.9 %SODIUM CHLORIDE SOLUTION 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 angioTDM objectifying a total cessation of intracranial circulation,
- And from whom a removal 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,
- Dosage of vasopressor agent amines that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor less than 7 mg / h at inclusion,
- euvolemic donor patient at inclusion,
Key exclusion criteria (16 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Potassium CanrenoateAlso: DrugAdministration 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 | Potassium canrenoate |
| IV Sodium Chloride 0.9 %Also: PlaceboAdministration 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. | Drug | Placebo (SODIUM CHLORIDE SOLUTION 0.9%) |
Primary outcome
Donor death (cardio circulatory arrest)
Time frame: from the randomization until the organ removal, up to 24 hours
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order: A. death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
Inability to perform kidney harvest
Time frame: Up to 24 hours, in the organ removal during surgery
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order: A. death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
The average hourly dose of norepinephrine or epinephrine
Time frame: From the randomization until the departure to the operating room, up to 24 hours
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order: A. death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
The average hourly volume of crystalloids and / or colloids
Time frame: from the randomization until the departure to the operating room, up to 24 hours
The primary endpoint will be a hierarchical composite of events, as described by Felker in 2010 (Circ HF - PMID 20841546) including in descending order: A. death (cardio circulatory arrest) before organ removal, B. the inability to perform the renal swab, C. the average hourly dose of noradrenaline / adrenaline between randomization 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.
3 secondary outcomes
Mortality rate of the kidney recipients
Time frame: 3 months, 1 year, 3 years, and 10 years from kidney transplant
Serum creatinine (in μmol / L) of kidney recipients
Time frame: 3 months, 1 year, 3 years, and 10 years from kidney transplant
Percentage of kidney recipients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m²
Time frame: 3 months after kidney transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 37821131Belarif L, Girerd S, Jaisser F, Lepage X, Merckle L, Duarte K, Girerd N, Guerci P. Potassium canrenoate in brain-dead organ donors: a randomised controlled clinical trial protocol (CANREO-PMO). BMJ Open. 2023 Oct 11;13(10):e073831. doi: 10.1136/bmjopen-2023-073831.
- Individual participant dataSharing planned: Yes. Data are available upon reseanable request to the principal investigator in compliance with french regulations.
Related trials for Brain-dead Organ Donors
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruiting
DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors
Organ Transplant
RecruitingObservational study
Endothelial Glycocalyx Damage in Brain Death Organ Donors
Brain Damage Due to Hypoxia, Organ Donors
RecruitingPhase 3
Anesthesia sTrategy foR Organ Procurement In braiN dEath
Brain-dead Organ Donors
RecruitingObservational study
Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures
Organ Preservation, Brain Reperfusion or Regain of Brain Function During Normothermic Regional Perfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe GUERCI, MD, PhD principal investigator
CHRU de NANCY
Nicolas GIRERD, MD-PhD study chair
CHRU de NANCY
Patrick ROSSIGNOL, MD-PhD study chair
CHRU de NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV Potassium Canrenoate and IV Sodium Chloride 0.9 % in people with Brain-dead Organ Donors, run by Pr. Nicolas GIRERD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor death (cardio circulatory arrest) (time frame: from the randomization until the organ removal, up to 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.