Renal Futility Following Simultaneous Liver-Kidney Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Simultaneous Liver-kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Renal allograft futility

This refers to the group meeting the primary outcome, which is the need for dialysis or occurrence of death at 3 months after simultaneous liver-kidney transplantation. This group defines the absence of renal function recovery post-transplant and thus renal graft failure, termed renal futility.

No interventions assigned to this group

Control group

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Nord, HCL

Lyon, France, France

Site Status

Countries

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France

Other Identifiers

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24-5281

Identifier Type: -

Identifier Source: org_study_id