De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study
NCT ID: NCT02909335
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-11-30
2021-11-30
Brief Summary
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Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and kidney transplant recipients. It preserves renal function when it is started soon after the transplant, i.e. before a severe dysfunction is installed.
Detailed Description
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We wish to assess whether the introduction of a de novo immunosuppression everolimus under protection of basiliximab induction, mycophenolate mofetil and then low doses of corticosteroids, reduces the nephrotoxicity of immunosuppressive therapy in liver transplant patients, compared to a standard protocol with tacrolimus associated with mycophenolate mofetil and low dose corticosteroids.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tacrolimus group
Tacrolimus + mycophenolate mofetil + corticosteroids
Everolimus
Everolimus is administered at an initial dose of 1.5 mg twice a day on Day 5.
The doses are then adjusted to maintain trough levels:
* between 6 and 10 ng / ml during the first 2 months,
* between 5-8 ng / ml from the start of the end M3 and M6,
* and between 4 and 6 ng / ml between the beginning and the end of M7 M12.
Mycophenolate mofetil
mycophenolate mofetil is administered similarly in the two groups at the dose of 1.5 g for the first two months and then 1 g twice a day. The doses may be adjusted according to the tolerance of the product.
Prednisolone, Prednisone or Methylprednisolone
Corticosteroid is similarly administered in both groups between baseline and the end of M6 and adjusted in case of acute rejection
Everolimus group
Everolimus + mycophenolate mofetil + corticosteroids
Tacrolimus
Tacrolimus is administered at an initial dose of 0.040 mg / kg twice a day on Day 5.
The doses are then adjusted to maintain trough levels :
* between 6 and 10 ng / ml during the first 2 months,
* between 5 and 8 ng / ml from the start of the end M3 and M6,
* and between 4 and 6 ng / ml between the beginning and the end of M7 M12.
Mycophenolate mofetil
mycophenolate mofetil is administered similarly in the two groups at the dose of 1.5 g for the first two months and then 1 g twice a day. The doses may be adjusted according to the tolerance of the product.
Prednisolone, Prednisone or Methylprednisolone
Corticosteroid is similarly administered in both groups between baseline and the end of M6 and adjusted in case of acute rejection
Interventions
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Tacrolimus
Tacrolimus is administered at an initial dose of 0.040 mg / kg twice a day on Day 5.
The doses are then adjusted to maintain trough levels :
* between 6 and 10 ng / ml during the first 2 months,
* between 5 and 8 ng / ml from the start of the end M3 and M6,
* and between 4 and 6 ng / ml between the beginning and the end of M7 M12.
Everolimus
Everolimus is administered at an initial dose of 1.5 mg twice a day on Day 5.
The doses are then adjusted to maintain trough levels:
* between 6 and 10 ng / ml during the first 2 months,
* between 5-8 ng / ml from the start of the end M3 and M6,
* and between 4 and 6 ng / ml between the beginning and the end of M7 M12.
Mycophenolate mofetil
mycophenolate mofetil is administered similarly in the two groups at the dose of 1.5 g for the first two months and then 1 g twice a day. The doses may be adjusted according to the tolerance of the product.
Prednisolone, Prednisone or Methylprednisolone
Corticosteroid is similarly administered in both groups between baseline and the end of M6 and adjusted in case of acute rejection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients due to receive a first liver transplant with a full or reduced graft taken from a donor brain-dead beating heart or a related living donor,
* Patients having given a free and informed written consent .
* Receiving basiliximab (Simulect)
* Whose immunosuppression regimen from day 5 could immediately consist of either tacrolimus or everolimus, in combination with mycophenolate mofetil and low dose corticosteroids
* With hepatic artery permeable to echo Doppler 4 days after transplant.
Exclusion Criteria
* Known hypersensitivity to the treatments or macrolides,
* HIV infection
* Autoimmune hepatitis,
* Primary sclerosing cholangitis,
* Programming or realization of a combined transplant,
* Pregnancy or lack of effective contraception,
* Breastfeeding.
* Incompatibility with the donor,
* Thrombosis of the hepatic artery between D0 and D4,
* Non-primary graft function leading to a re-registration on the waiting list.
18 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Karim BOUDJEMA, MD, PhD
Role: STUDY_DIRECTOR
CHU Rennes
Countries
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Other Identifiers
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2013-003802-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
35RC12_8985
Identifier Type: -
Identifier Source: org_study_id