At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Everolimus 0.75mgfrom 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 Prospective, Randomized, Single Center Pilot Study Comparing Patient and Graft Survival, Adverse Events and Tolerability of Zortress® (Everolimus) Versus Rapamune® (Sirolimus) in Combination With Low Dose Neoral® (Cyclosporine) Dosed by C2 Monitoring, in Deceased and Living Donor Renal Transplant Recipients Under a Thymoglobulin® (Antithymocyte Globulin) and Rapid Steroid Induction Protocol.
In Brief
A clinical study evaluating Everolimus and Sirolimus for Renal Failure. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure
CountriesUnited States
CollaboratorsNovartis
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedNov 2013
Primary CompletionJul 2018
Study CompletionAug 2019
TodayJul 2026
First PostedNov 5, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 11, 2018
Study CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.7 years ago
Interventions
Everolimusdrug
0.75mg twice a day, Orally, starting on day of transplant
Sirolimusdrug
5mg, Orally, starting on day of transplant; decreasing to 3mg