Safety Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction

Summary

Renal dysfunction in the context of liver transplantation is a major issue, with difficult patients' management and determining a worsened prognosis.

Physiopathologically pretransplant renal dysfunction is dependent on multifactorial causes, including hypoperfusion-derived functional renal insufficiency, hepatorenal syndrome or interstitial parenchymatous insufficiency. On top, intra- or post-transplant events, including hypoperfusion or calcineurin inhibitors nephrotoxicity may aggravate this situation.

At present MELD criteria favours allocation of organs to patients suffering from renal insufficiency, so at least 30% of the investigators liver transplant patients suffer from some degree of renal impairment pretransplant.

After liver transplant impaired renal function tends to recover partially or completely, unless advanced parenchymatous lesions are significantly involved as a major cause of renal dysfunction.

In this context, calcineurin inhibitors avoiding or sparing protocols may help in the recovery from renal insufficiency, improving long-term prognosis. The use of anti-CD25 antibodies is a good option, but provides a limited antirejection prophylaxis, limiting the use of these antibodies to a reduced cohort of liver transplant patients.

Polyclonal antibodies might provide an advantage in management of liver transplant patients with renal insufficiency, without increasing acute rejection episodes of the allograft efficacy and security evaluation of low nephrotoxicity immunosuppression, based on the use of ATeGe, in liver transplant candidates with pre-transplant renal dysfunction.

The aim of this study is to evaluate the efficacy and security use of immunosuppression based on ATeGe in liver transplant recipients with pre-transplant renal dysfunction.

Conditions

• Renal Insufficiency

Interventions

DRUG

ATeGe-Fresenius

Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  collaborator OTHER

• Hospital Vall d'Hebron

  lead OTHER

Principal Investigators

• ITXARONE BILBAO, PhD/MD · Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)

• RAMON CHARCO, PHD/MD · Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)

• CRISTINA DOPAZO, PhD/MD · Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)

• MONICA MARTINEZ, PhD/MD · Department of Inmunology, Hospital Vall d´Hebron (Barcelona, Spain)

• GONZALO SAPISOCHIN, PhD/MD · Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)

• JOSE L LAZARO, MD · Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)

• HELENA ALLENDE, PhD/MD · Department of Histology, Hospital Vall d´Hebron (Barcelona, Spain)

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2020-02-29

Completion

2020-02-29

Countries

• Spain

Study Locations