At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 130 enrolled
Drug / intervention
standard therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating standard therapy and Everolimus for Lung Transplantation. Completed, enrolled 130 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Transplantation
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartFeb 2012
Primary CompletionJan 2017
TodayJul 2026
First PostedJul 28, 2011
Enrollment StartFeb 1, 2012
Primary CompletionJan 5, 2017
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 14.9 years ago
Interventions
standard therapydrug
centre specific CNI-based triple drug immunosuppression
Everolimusdrug
quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids