Efficacy and Safety of AEB071 Versus Cyclosporine in de N... | NCT00820911 | Trialant

Efficacy and Safety of AEB071 Versus Cyclosporine in de N... | NCT00820911 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cyclosporine (reduced exposure) / everolimus	Active Comparator		Drug: cyclosporine (reduced exposure) / everolimus
AEB071 300 mg b.i.d. / everolimus	Experimental		Drug: AEB071 300 mg b.i.d. / everolimus
AEB071 200 mg b.i.d. / everolimus	Experimental		Drug: AEB071 200 mg b.i.d. / everolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Contacts/Locations Module

Ancestor Terms

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