NCT01404325

Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy Regarding Renal Function of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, Purinantagonists and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.

Conditions

• Lung Transplantation

Interventions

Type	Name	Description
DRUG	standard therapy	centre specific CNI-based triple drug immunosuppression
DRUG	Everolimus	quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids

Timeline

• Start date: 2012-02-01
• Primary completion: 2017-01-05
• Completion: 2017-01-05
• First posted: 2011-07-28
• Last updated: 2019-03-14
• Results posted: 2019-03-14

Locations

9 sites across 1 country: Germany