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MMF+ full-dose Neoral+ corticosteroids

Phase 3

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Aug 22, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment696

FDA Designations

No designations recorded

Clinical trial landscape

MMF+ full-dose Neoral+ corticosteroids · 1 trial · 1 indication

Phase 3 1
NCT00099736Efficacy and Safety of FTY720 in Patients Who Receive a Kidney TransplantKidney Transplantation
COMPLETED696 Analytics
PHASE3COMPLETED
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
Kidney Transplantation
NCT00099736696
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Study Endpoints

Primary Endpoints

IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
permanent resumption of dialysis within 12 months post transplant
surgical removal of graft within 12 months post transplant
death within 12 months post transplant
withdrawal of consent, death, or lost to follow up within 12 months post transplant

Secondary Endpoints

FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
serum creatinine
cystatin C at months 3, 6, and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,EXPERIMENTAL -
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroidsEXPERIMENTAL -
MMF 2 g + full-dose Neoral (FDN) + corticosteroidsEXPERIMENTAL -

Interventions

NameTypeDescription
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroidsDRUGFTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroidsDRUGFTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
MMF 2 g + full-dose Neoral (FDN) + corticosteroidsDRUGmycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * First kidney transplantation * Male and female patients * Between 18 and 65 years old Exclusion Criteria: * Patients in need of multiple organ transplants

Countries:United States
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Frequently asked questions about MMF+ full-dose Neoral+ corticosteroids

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 combines mycophenolate mofetil, cyclosporine microemulsion, and prednisone. The regimen was evaluated in Phase 3 clinical trials for these indications.

Who makes MMF+ full-dose Neoral+ corticosteroids?

MMF+ full-dose Neoral+ corticosteroids is developed by Novartis AG, which trades under the ticker NVS. The company sponsored clinical trials of this combination regimen in kidney transplant patients.

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 and remains in clinical development. No approval status has been reported for this regimen.

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 adult kidney transplant patients in the United States. NCT00228020 enrolled 212 pediatric kidney transplant recipients aged 1 year and older.

Is MMF+ full-dose Neoral+ corticosteroids the same as a standard immunosuppressive regimen?

MMF+ full-dose Neoral+ corticosteroids refers to a specific combination of mycophenolate mofetil, full-dose cyclosporine microemulsion (Neoral), and corticosteroids. This regimen was used as a comparator in trials testing other immunosuppressive agents in kidney transplantation.