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MMF+ tacrolimus+ standard of care medications

Phase 2

Liver Transplantation | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Dec 22, 2020

Target and mechanism

ModalitySmall molecule

Also known as MMF, cyclosporine, steroids, MMF

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

MMF+ tacrolimus+ standard of care medications · 1 trial · 1 indication

Phase 2 1
NCT01128335Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant PatientsLiver Transplantation
COMPLETED200 Analytics
PHASE2COMPLETED
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
Liver Transplantation
NCT01128335200
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Study Endpoints

Primary Endpoints

Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
Month 6

Secondary Endpoints

Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).
Months 3, 6, 12, and 24
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
Months 12, 24
Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant
Months 6, 12, 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATORMMF(1000mg bid) + tacrolimus + standard of care medications
Arm 2EXPERIMENTALsotrastaurin (200mg bid) + tacrolimus + standard of care medications
Arm 3EXPERIMENTALsotrastaurin (200mg bid) + tacrolimus + standard of care medications
Arm 4EXPERIMENTALsotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Interventions

NameTypeDescription
MMF(1000mg bid) + tacrolimus + standard of care medicationsDRUGMMF(1000mg bid) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medicationsDRUGsotrastaurin (200mg bid) + tacrolimus + standard of care medications
sotrastaurin (300 mg bid) + tacrolimus + standard of care medicationsDRUGsotrastaurin (300 mg bid) + tacrolimus + standard of care medications
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion criteria: * Recipients of any race, 18 years or older * Recipients of primary de novo orthotopic liver transplant from a deceased donor * Recipients of a kidney with a cold ischemia time \< 30 hours * HCV-negative recipients Exclusion criteria: * Prior organ/cellular transplant or multi...

Countries:United StatesArgentinaAustriaBelgiumCanadaCzechiaFinlandFranceGermanyItalySpainSwitzerland
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Frequently asked questions about MMF+ tacrolimus+ standard of care medications

What is MMF+ full-dose Neoral+ corticosteroids used for?

MMF+ full-dose Neoral+ corticosteroids is a combination regimen studied for use in kidney transplantation, including pediatric kidney transplantation. It was evaluated in Phase 3 clinical trials in patients receiving a kidney transplant and in pediatric renal allograft recipients.

Who makes MMF+ full-dose Neoral+ corticosteroids?

MMF+ full-dose Neoral+ corticosteroids is developed by Novartis AG, which trades under the ticker NVS. The regimen combines mycophenolate mofetil, cyclosporine microemulsion, and prednisone, and has been studied in Phase 3 trials for kidney transplantation.

What phase is MMF+ full-dose Neoral+ corticosteroids in?

MMF+ full-dose Neoral+ corticosteroids has completed Phase 3 clinical trials. It is an investigational combination regimen for kidney transplantation and pediatric kidney transplantation. The trials were completed, and the regimen remains in clinical development.

What clinical trials is MMF+ full-dose Neoral+ corticosteroids in?

MMF+ full-dose Neoral+ corticosteroids was studied in two completed Phase 3 trials. NCT00099736 enrolled 696 adults with kidney transplantation, and NCT00228020 enrolled 212 pediatric patients with kidney transplantation. Both trials were randomized, double-blind, and controlled.

Is MMF+ full-dose Neoral+ corticosteroids the same as a basiliximab, mycophenolate mofetil, cyclosporine microemulsion and prednisone combination?

MMF+ full-dose Neoral+ corticosteroids refers to a regimen of mycophenolate mofetil, full-dose cyclosporine microemulsion (Neoral), and corticosteroids. A related trial, NCT00228020, studied a combination of basiliximab, mycophenolate mofetil, cyclosporine microemulsion, and prednisone in pediatric kidney transplant recipients.