Clinical trial NCT06712537: Renal Futility Following Simultaneous Liver-Kidney Transplantation
Official title: Renal Futility Following Simultaneous Liver-Kidney Transplantation: What Identified Risk Factors to Avoid It?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Simultaneous Liver-kidney Transplantation
Keywords: Simultaneous liver-kidney transplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects who underwent simultaneous liver-kidney transplantation between January 1, 2013, and December 31, 2022, in France

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.


Eligibility 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

Primary outcomes:
measure: Renal futility, defined as the need for dialysis (intermittent or continuous) or occurrence of death at 3 months after simultaneous liver-kidney transplantation
timeFrame: The outcome is collected at 3 months following the simultaneous liver-kidney transplantation.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Nord, HCL
Study officials:
References: