Safety Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction (ATG_HVH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01453218|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : February 12, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency||Drug: ATeGe-Fresenius||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2020|
|Actual Study Completion Date :||February 2020|
No Intervention: Basiliximab
Historical comparable cohort treated with Basiliximab 20mg iv administered at 0 and 4th day post-transplant
|Active Comparator: ATeGe-Fresenius||
Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels
- Renal function improvement after liver transplant [ 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 ]Creatinine (mg/dL) and MDRD Glomerular Filtrate Rate (ml/min/1.73m2) will be measured following the time frame described above
- Incidence of biopsy proven acute cellular rejection. [ Time Frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant ]If liver dysfunction is detected, percutaneous liver biopsy will be performed and histological severity will be assed following BANF criteria
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453218
|Department of HPB Surgery and Transplants, Hospital Vall d´Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||ITXARONE BILBAO, PhD/MD||Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)|
|Study Director:||RAMON CHARCO, PHD/MD||Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)|
|Study Chair:||CRISTINA DOPAZO, PhD/MD||Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)|
|Study Chair:||MONICA MARTINEZ, PhD/MD||Department of Inmunology, Hospital Vall d´Hebron (Barcelona, Spain)|
|Study Chair:||GONZALO SAPISOCHIN, PhD/MD||Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)|
|Study Chair:||JOSE L LAZARO, MD||Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)|
|Study Chair:||HELENA ALLENDE, PhD/MD||Department of Histology, Hospital Vall d´Hebron (Barcelona, Spain)|