Renal Insufficiency Clinical Trial
Official title:
Single Centre, Prospective, Open, Non Controlled, Pilot Study for Efficacy and Security Evaluation of Low Nephrotoxicity Immunosuppression, Based on the Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction
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.
n/a
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