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Health Condition(s) or Problem
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Liver Transplantation
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; Advagraf; Capsule; Dosing Regimen 1; Dosing Regimen 2; Dosing Regimen 3; FK506E; MR4; tacrolimus modified release; Drug; Mycophenolate Mofetil; Solution for infusion; Dosing Regimen 1; Dosing Regimen 2; Dosing Regimen 3; MMF; Drug; Basiliximab; IV infusion; Dosing Regimen 2; Dosing Regimen 3; Simulect; Drug; Corticosteroids; IV bolus; Dosing Regimen 1; Dosing Regimen 2; Dosing Regimen 3; Methylprednisolone or equivalent
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Primary aim
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Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula
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Secondary Aim
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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; No; GFR at 24 Weeks after transplantation measured by Iothalamate clearance; 24 weeks; Yes; GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula; 24 weeks; Yes; Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula; 24 weeks; Yes; Incidence of and time to first incidence of acute rejection; 24 weeks; No; Incidence of and time to first incidence of corticosteroid-resistant acute rejection; 24 weeks; No; Overall frequency of acute rejection episodes; 24 weeks; No; Incidence of and time to first incidence of biopsy confirmed acute rejection; 24 weeks; No; Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection; 24 weeks; No; Overall frequency of biopsy confirmed acute rejection episodes; 24 weeks; No; Severity of biopsy confirmed acute rejection episodes; 24 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Birmingham, Leeds, London
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