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Renal Futility Following Simultaneous Liver-Kidney Transplantation

Renal Futility Following Simultaneous Liver-Kidney Transplantation: What Identified Risk Factors to Avoid It?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06712537
Acronym
FUTILITY
Enrollment
452
Registered
2024-12-02
Start date
2024-05-01
Completion date
2025-05-31
Last updated
2024-12-02

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

Conditions

Simultaneous Liver-kidney Transplantation

Keywords

Simultaneous liver-kidney transplantation

Brief summary

Liver transplantation in France represents a currently significant transplantation activity with a steady increase in the number of transplanted patients, with 1,294 liver transplants according to the Biomedicine Agency in 2022 compared to 806 liver transplants in 2000. 4% of these transplanted patients, or 54, underwent combined liver-kidney transplantation in 2022. The indication for combined transplantation fits within several scenarios: patients indicated for liver transplantation with severe renal insufficiency as a comorbidity, which worsens the prognosis in the case of liver transplantation alone; patients with renal insufficiency indicated for kidney transplantation with decompensated liver disease as a comorbidity; and diseases affecting both organs in a combined and severe manner. However, some American studies have highlighted the significant prevalence of kidney transplant failure during simultaneous liver-kidney transplantation, estimated at around 20% at 3 months post-transplant. This failure of renal function recovery after the double transplant is defined by the need for dialysis or the occurrence of death. This represents a major issue concerning the mortality and morbidity of patients who have undergone simultaneous liver-kidney transplantation. The aim of this study is to identify the risk factors for failure of renal function recovery after combined liver-kidney transplantation, thus indicating the futility of the kidney transplant in this context of double transplantation. The outcomes will be multiple. On one hand, we will identify the population most suitable to benefit from this intervention, which will improve recommendations on access to simultaneous liver-kidney transplantation. On the other hand, we will develop an optimized strategy for the use of available grafts, in order to better address the current organ shortage and the increasing number of patients waiting for transplants.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Inclusion Criteria \* : * adult patient * having undergone simultaneous liver-kidney transplantation between January 1, 2013, and December 31, 2022 * in France *

Exclusion criteria

\* : * multi-organ transplant other than simultaneous liver-kidney transplantation * liver or kidney transplant alone * minor patient * refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Renal futility, defined as the need for dialysis (intermittent or continuous) or occurrence of death at 3 months after simultaneous liver-kidney transplantationThe outcome is collected at 3 months following the simultaneous liver-kidney transplantation.The primary outcome is met if the patient undergoes dialysis (continuous or intermittent) or is dead at 3 months after simultaneous liver-kidney transplantation. The outcome is not met if the patient required dialysis during the early stages of their transplant but no longer needs it and is not undergoing dialysis at 3 months. The criterion is not met if the patient dies after the 3-month period following simultaneous liver-kidney transplantation. This outcome is collected from electronic medical records by designated and authorized personnel. These records are stored within the hospital departments where patients are being monitored.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026