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AEB071 b.i.d./ everolimus

Phase 2

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Feb 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

AEB071 b.i.d./ everolimus · 1 trial · 1 indication

Phase 2 1
NCT00820911Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant RecipientsKidney Transplantation
COMPLETED175 Analytics
PHASE2COMPLETED
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
Kidney TransplantationUnlock trial analytics

Study Endpoints

Primary Endpoints

renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Secondary Endpoints

efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
cyclosporine (reduced exposure) / everolimusACTIVE_COMPARATOR -
AEB071 300 mg b.i.d. / everolimusEXPERIMENTAL -
AEB071 200 mg b.i.d. / everolimusEXPERIMENTAL -

Interventions

NameTypeDescription
cyclosporine (reduced exposure) / everolimusDRUGtwice daily
AEB071 300 mg b.i.d. / everolimusDRUGtwice daily
AEB071 200 mg b.i.d. / everolimusDRUGtwice daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion criteria: * Patient has been maintained on study drug for 12 months in the core study Exclusion criteria: * Not applicable * Other protocol-defined inclusion/exclusion criteria may apply

Countries:ArgentinaAustraliaAustriaBelgiumBrazilColombiaCzechiaFranceGermanyItalyNetherlandsNorwaySingaporeSlovakiaSpainSwitzerlandTaiwan
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Frequently asked questions about AEB071 b.i.d./ everolimus

What is AEB071 b.i.d./ everolimus used for?

AEB071 b.i.d./ everolimus is an investigational small molecule being studied for use in kidney transplantation. It is being evaluated as a treatment for de novo renal transplant recipients, meaning patients who have recently received a kidney transplant. The drug is currently in Phase 2 clinical development.

Who makes AEB071 b.i.d./ everolimus?

AEB071 b.i.d./ everolimus is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in kidney transplant patients.

What phase is AEB071 b.i.d./ everolimus in?

AEB071 b.i.d./ everolimus is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for use in kidney transplantation, specifically in de novo renal transplant recipients.

What clinical trials is AEB071 b.i.d./ everolimus in?

AEB071 b.i.d./ everolimus has been studied in a Phase 2 clinical trial with the identifier NCT00820911. This trial, titled 'Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients,' enrolled 175 participants and has been completed. The trial was conducted across multiple countries including Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czechia, France, Germany, Italy, Netherlands, Norway, Singapore, Slovakia, Spain, Switzerland, and Taiwan.

Is AEB071 b.i.d./ everolimus the same as cyclosporine?

AEB071 b.i.d./ everolimus is not the same as cyclosporine. In the clinical trial NCT00820911, AEB071 was compared against cyclosporine in de novo renal transplant recipients. The trial was active-controlled, meaning AEB071 was tested against an active comparator, cyclosporine, to evaluate its efficacy and safety.