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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain
Renal function improvement after liver transplant
Creatinine (mg/dL) and MDRD Glomerular Filtrate Rate (ml/min/1.73m2) will be measured following the time frame described above
Time frame: Measurement will be performed at 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th and 28th day post-transplant, and 2nd, 3rd, 6th and 12th month post-transplant
Incidence of biopsy proven acute cellular rejection.
If liver dysfunction is detected, percutaneous liver biopsy will be performed and histological severity will be assed following BANF criteria
Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant
Patient and graft survival rates after 12 months, causes of death and retransplant
Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant
Relationship between ATeGe doses, immunological variables (lymphocyte counts) and clinical adverse events (acute rejection,infections, HCV recurrence and de novo tumor)
Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant
Incidence and severity of HCV infection recurrence, based on clinical and histological criteria.
Time frame: Once liver dysfunction is detected and one year post-transplant by protocol.
Evaluation of metabolic complications (diabetes mellitus, arterial hypertension and dyslipidemia)
Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant
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