NCT06344442 Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial)
| NCT ID | NCT06344442 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Kidney Injury Post Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2025-05-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 304 participants in total. It began in 2025-04-16 with a primary completion date of 2025-05-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality. Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtration The hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Any adult patient with a scheduled liver transplantation * All participants will need to be given clear information about the study and give signed informed consent. * Person affiliated to the Social Security Exclusion Criteria: * Super-emergency for liver transplantation or fulminant hepatitis * Patient listed for or receiving simultaneous liver-kidney transplantation (SLKT) * Patients with end-stage renal disease (chronic eGFR \< 15 mL/min/1.73 m2 or requiring extra-renal purification before liver transplantation * Patient with epilepsy * Hypersensitivity to arginine-vasopressin and to its excipients * Patient refusal * Patients for whom it is impossible to give informed consent (language barrier) * Adults under guardianship or trusteeship, persons deprived of their liberty * Patient enrolled in another interventional clinical study * Pregnancy or breastfeeding
Contact & Investigator
Jacques DURANTEAU, Pr
STUDY DIRECTOR
Département Anesthésie-Réanimation - Université Paris-Saclay Hospital Bicêtre - Paul Brousse
Frequently Asked Questions
Who can join the NCT06344442 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury Post Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06344442 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 304 participants.
Is NCT06344442 currently recruiting?
Yes, NCT06344442 is actively recruiting participants. Contact the research team at jacques.duranteau@aphp.fr for enrollment information.
Where is the NCT06344442 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06344442 clinical trial?
NCT06344442 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Jacques DURANTEAU, Pr at Département Anesthésie-Réanimation - Université Paris-Saclay Hospital Bicêtre - Paul Brousse. The trial plans to enroll 304 participants.
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