At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 108 enrolled
Drug / intervention
Ciclosporin and Mycophenolate-mofetil +2 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.
Prospective Randomized Study to Characterize Risk Factors of Polyomavirus-related Transplant Nephropathy and the Impact of Three Immunosuppressive Regimens on Nephropathy Incidence
In Brief
A Phase 4 clinical trial evaluating Ciclosporin and Mycophenolate-mofetil, Tacrolimus and Mycophenolate-mofetil, and 1 other intervention for Polyomavirus Infections. Completed, enrolled 108 participants across 1 site.
Detailed Summary
The aim of this study is to characterize and evaluate risk factors of polyomavirus nephropathy (PVN) including the impact of three immunosuppressive regimens.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolyomavirus Infections
CountriesGermany
CollaboratorsHeidelberg University, Hoffmann-La Roche, Astellas Pharma Inc, Novartis
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedSep 2005
Primary CompletionMar 2010
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartSep 1, 2004
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.8 years ago
Interventions
Ciclosporin and Mycophenolate-mofetildrug
according to the Giessen protocol
Tacrolimus and Mycophenolate-mofetildrug
according to Giessen protocol
Tacrolimus and Mycophenolate-mofetil with change from Mycophenolate-mofetil to Everolimusdrug
according to Giessen protocol