Efficacy, Safety and Tolerability of AEB071 Versus Cyclos... | NCT00504543

Official Title

A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Neoral	Active Comparator	Drug: Neoral
AEB071 high dose with Cetican reduced dose	Active Comparator	Drug: AEB071 Drug: Certican
AEB071 low dose with Cetican standard dose	Active Comparator	Drug: AEB071 Drug: Certican

Name	Type	Description	Arm Group Labels	Other Names
AEB071	Drug	oral, twice daily	AEB071 high dose with Cetican reduced dose AEB071 low dose with Cetican standard dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK		12 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Argentina		Buenos Aires		1107	Argentina
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23659755	Result	Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
C543528	sotrastaurin
D000068338	Everolimus
D016572	Cyclosporine

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins