At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 86 enrolled
Drug / intervention
sirolimus +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Kidney transplant performed at least 1 year prior to enrollment
- ✓Functioning renal allograft with GFR ≥40 mL/min (Nankivell method)
- ✓Proteinuria ≤500 mg/day
- ✓Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
Key exclusion· 4
- ✕History of cancer other than NMSC within the last 3 years
- ✕NMSC with metastatic disease
- ✕More than 20 NMSC lesions in the last 12 months
- ✕Multiple organ transplant recipient
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label Study to Compare the Rate of New Non-Melanoma Skin Cancer in Maintenance Renal Allograft Recipients Converted to a Sirolimus-based Regimen Versus Continuation of a Calcineurin Inhibitor-based Regimen
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 12, 2005·Updated Apr 11, 2012
In Brief
A Phase 4 clinical trial evaluating sirolimus and cyclosporine or tacrolimus for Skin Neoplasms and Kidney Transplantation. Completed, enrolled 86 participants across 23 sites in 4 countries.
Detailed Summary
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Neoplasms, Kidney Transplantation
CountriesAustralia, Canada, New Zealand, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2005
First PostedAug 2005
Primary CompletionJan 2009
TodayJul 2026
First PostedAug 12, 2005
Enrollment StartAug 1, 2005
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.9 years ago
Interventions
sirolimusdrug
cyclosporine or tacrolimusdrug