NCT02096107

Novartis Everolimus Transition

Safety and Efficacy of Everolimus Transition in Minimizing Progressive Graft Dysfunction and Interstitial Fibrosis in Adult Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.

Conditions

• Graft Dysfunction
• Interstitial Fibrosis

Interventions

Type	Name	Description
DRUG	Everolimus	Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus
OTHER	Standard of Care	Tacrolimus, mycophenolate mofetil and steroids

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-03-26
• Last updated: 2018-08-08
• Results posted: 2018-08-08

Locations

1 site across 1 country: United States