Clinical trial · Interventional
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
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
NCT00129961CI-TRIAL-00006700completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Transplantation | — | UNRESOLVED | — |
| Skin Neoplasms | Skin Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine or tacrolimus | Drug | — | UNRESOLVED |
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Conversion to a sirolimus-based regimen
- interventionNames
- Drug: sirolimus
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Continuation of a CNI-based regimen
- interventionNames
- Drug: cyclosporine or tacrolimus
Primary outcomes (1)
- measure
- New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
- timeFrame
- up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Kidney transplant at least 1 year prior * Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day. * Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen * History of NMSC within last 3 years Exclusion Criteria: * History of other cancer within last 3 years * NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months * Multiple organ transplant
References
Publications (1)
- DERIVEDCampbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15. PMID 22420843