NCT01843348

12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.

Conditions

• Kidney Transplantation
• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus
DRUG	Tacrolimus	Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels
DRUG	Cyclosporin A	Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml
DRUG	Enteric Coated Mycophenolate Sodium (EC-MPS)	Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose
DRUG	Mycophenolate mofetil (MMF)	Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose
DRUG	Corticosteroids	A minimum dose of 5 mg prednisolon or equivalent
DRUG	Simulect	Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

Timeline

• Start date: 2012-12-27
• Primary completion: 2016-03-23
• Completion: 2016-03-23
• First posted: 2013-04-30
• Last updated: 2017-05-01
• Results posted: 2017-05-01

Locations

27 sites across 2 countries: France, Germany