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cyclosporin+ mycophenolate mofetil

Phase 3

Kidney Failure | Small molecule | Nephrology |Novartis AG|Last Updated: Jun 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

cyclosporin+ mycophenolate mofetil · 1 trial · 1 indication

Phase 3 1
NCT01595984Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)Kidney Failure
COMPLETED88 Analytics
PHASE3COMPLETED
Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)
Kidney FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Evolution of glomerular filtration rate measured by clearance of iohexol
one year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cyclosporin + Mycophenolate mofetilACTIVE_COMPARATOR -
Everolimus + mycophenolate mofetilEXPERIMENTAL -

Interventions

NameTypeDescription
cyclosporin + mycophenolate mofetilDRUGantirejection drug, renal transplantation
everolimus + mycophenolate mofetilDRUGantirejection drug, renal transplantation
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males and Females aged between 18 and 70. * Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated. * Patient with a maximum PRA \<20%. * Patient wishing and being able to participate fully to the study, and having given a writ...

Countries:France
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Recent Changes (Last 90 Days)

MEDIUMJul 13, 2026NCT01595984TRIAL_REMOVED: changed
MEDIUMJul 13, 2026NCT01595984TRIAL_REMOVED: changed
MEDIUMJul 13, 2026NCT01595984TRIAL_REMOVED: changed

Frequently asked questions about cyclosporin+ mycophenolate mofetil

What is cyclosporin + mycophenolate mofetil used for?

Cyclosporin + mycophenolate mofetil is used for kidney failure, specifically in the context of renal transplantation. It is a combination of two small molecule immunosuppressants being studied to compare the efficacy and safety of a calcineurin inhibitor (CNI) versus a CNI-free treatment regimen in kidney transplant patients.

Who makes cyclosporin + mycophenolate mofetil?

Cyclosporin + mycophenolate mofetil is developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this combination therapy for kidney failure patients undergoing renal transplantation.

What phase is cyclosporin + mycophenolate mofetil in?

Cyclosporin + mycophenolate mofetil is in Phase 3 clinical development. It is an investigational combination therapy for kidney failure and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is cyclosporin + mycophenolate mofetil in?

Cyclosporin + mycophenolate mofetil was studied in a single Phase 3 clinical trial, NCT01595984, titled 'Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI) Versus a CNI-free Treatment in Renal Transplantation (CIME)'. This completed trial enrolled 88 participants in France and was active-controlled, randomized, and biomarker-selected.

Is cyclosporin + mycophenolate mofetil the same as a CNI-free treatment?

No, cyclosporin + mycophenolate mofetil is not the same as a CNI-free treatment. The combination includes cyclosporin, which is a calcineurin inhibitor (CNI). The clinical trial NCT01595984 compares this CNI-containing regimen against a CNI-free treatment to evaluate their relative efficacy and safety in renal transplantation.