A 24-month, Multi-center, Single Arm, Prospective Study to Evaluate Renal Function, Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

NCT01598987 Phase 3 COMPLETED Results posted

This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	56
Start date	2012-10
Completion	2016-06

Conditions

• Renal Function
• Liver Transplant

Interventions

• Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.

Primary outcomes

• Change From Baseline in Estimated Glomerular Filtration Rate - Month 12 — Baseline, Month 12
  Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.

Countries

United States, Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Spain, Sweden, United Kingdom