Status:
COMPLETED
Safety Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction
Lead Sponsor:
Hospital Vall d'Hebron
Collaborating Sponsors:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 dysfunct...
Eligibility Criteria
Inclusion
- Patients with moderate pre-transplant renal dysfunction as defined serum creatinine levels higher than 1.5 mg/dl or eGFR (MDRD-4) \<60ml/min.
- First liver transplant, including splits liver transplant.
- Patients aged 18-70 years
- Without a prior contraindication for protocol biopsy of allograft.
Exclusion
- Multiorgan transplantation and/or liver transplant from DCD and/or with ABO incompatibility.
- Uncontrolled concomitant infections (including HIV seropositivity) and/or diarrhoea, vomiting or active gastric ulcer.
- Fulminant hepatic insufficiency as first indication for liver transplant
- Hemodynamic instability prior to liver transplant.
- Recipient presenting present or previous neoplasia, except for non-metastatic basal or squamous cutaneous carcinoma or localized hepatocarcinoma with diameter \<5 cm or \< 3 known lesions with diameter \<3 cm.
- Intolerance to study medication.
- Patients having received vaccination with attenuated living vaccines within the previous 4 weeks.
- Severe leukopenia (\< 1.2 X 10E9/L) and/or thrombocytopenia (\< 50x10E9/L) and/or lymphocyte counts (CD2+/CD3+) less than 10 cells/µl.
- Significant comorbidity.
- Breastfeeding or female patients at fertile age without negative pregnancy test and accepting the use of reliable fertility control method.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01453218
Start Date
October 1 2011
End Date
February 1 2020
Last Update
February 12 2020
Active Locations (1)
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1
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain, 08035