NCT01950819

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,037 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

Conditions

• End Stage Renal Disease (ESRD)
• Chronic Kidney Disease (CKD)
• Hemodialysis
• Renal Replacement Therapy
• Renal Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Induction therapy	All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
DRUG	Corticosteroids	All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
DRUG	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
DRUG	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Timeline

• Start date: 2013-12-03
• Primary completion: 2017-02-01
• Completion: 2018-01-17
• First posted: 2013-09-26
• Last updated: 2019-01-30
• Results posted: 2019-01-30

Locations

184 sites across 42 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye)