Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01453218
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01453218
Study Brief:
Protocol Section:
NCT01453218