A 12 Month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients
18 Years
65 Years
Both
Liver Transplantation
Trial Information
A 12 Month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients
Inclusion Criteria
Inclusion criteria:
- Male or female recipients of a full-size liver allograft, aged 18 to 65 years.
Exclusion criteria:
- Patients with thrombocytopenia (platelets <100,000/mm³), with an absolute neutrophil
count of <1,500/mm³ or leucopenia (leucocytes <3000/mm³), with anemia with Hb < 8g/dl
at time of screening
- Patients with uncontrolled hypercholesterolemia (>330mg/dL; >9mmol/L) or
hypertriglyceridemia (>300 mg/dL; >8.5 mmol/L) at time of screening
- History of malignancy of any organ system within the past 5 years whether or not
there is evidence of local recurrence or metastases, other than non-metastatic basal
or squamous cell carcinoma of the skin or HCC (see next criteria).
- Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver
Outcome Description:
Immunosuppressive regimen based on everolimus (EVR) in coexposure with tacrolimus (TAC) compared to tacrolimus alone on estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver transplant recipients.
Outcome Time Frame:
at 12 months after randomization
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
CRAD001HDE13
NCT ID:
NCT01551212
Start Date:
May 2012
Completion Date:
Related Keywords:
- Liver Transplantation
- Liver transplantation
- everolimus
- kidney function
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