Liver Transplantation
Conditions
Keywords
Immunosuppression, Liver, Transplant, Advagraf
Brief summary
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
Interventions
DRUGAdvagraf
Capsule
DRUGMycophenolate Mofetil
Solution for infusion
DRUGBasiliximab
IV infusion
DRUGCorticosteroids
IV bolus
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing orthotopic liver or split liver allograft transplantation * Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Exclusion criteria
* Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation) * Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used * Receiving ABO incompatible graft or a graft from a non heart beating donor * Ongoing dosing with systemic corticosteroids * Subjects with systemic infection requiring treatment except viral hepatitis * Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria: * \< 3 nodes * no node larger than 5 cm * no metastases * no vascular tumoral invasion * Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer * Subject or donor known to be HIV positive * Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients * Pregnant woman or breast-feeding mother * Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment * Unlikely to comply with the Visits scheduled in the protocol * Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator * Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment * Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula | 24 weeks |
| Incidence of and time to first incidence of corticosteroid-resistant acute rejection | 24 weeks |
| Overall frequency of acute rejection episodes | 24 weeks |
| Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula | 24 weeks |
| Incidence of and time to first incidence of acute rejection | 24 weeks |
| GFR at 24 Weeks after transplantation measured by Iothalamate clearance | 24 weeks |
| Incidence of and time to first incidence of biopsy confirmed acute rejection | 24 weeks |
| Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection | 24 weeks |
| Overall frequency of biopsy confirmed acute rejection episodes | 24 weeks |
| Severity of biopsy confirmed acute rejection episodes | 24 weeks |
| Incidence of and time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) | 24 weeks |
Countries
Argentina, Austria, Belarus, Belgium, Brazil, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, Ireland, Italy, Mexico, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed