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Phase 3

Renal Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Mar 30, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00425308Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.PHASE3 COMPLETED 30 — — Oct 1, 2006 -Mar 30, 20171 France
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Study Endpoints
Primary Endpoints
Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
From Baseline to Month 12

Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
From Baseline to Month 12

Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

Secondary Endpoints
Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12
From Baseline to Month 3, 6, and 12
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
Month 6 and 12
Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.
Month 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)ACTIVE_COMPARATOREverolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
Everolimus + CyclosporineACTIVE_COMPARATOREverolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
Interventions
NameTypeDescription
Everolimus + CyclosporineDRUG -
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)DRUG -
SteroidsDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Patients who participated in and completed study CRAD001A2420 Exclusion criteria: * Premature study or study treatment discontinuation in CRAD001A2420 study. * Acute rejection within the 3 months prior to inclusion Other protocol-defined inclusion/exclusion criteria may app...

Countries:France
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