Phase 4
N=86
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
Skin Neoplasms · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00129961 ↗Enrolled (actual)
86
Serious AEs
41.9%
Results posted
Mar 2012
Primary outcome: Primary: New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year — 1.31; 2.48 Standardized Yearly Rate of NMSC — p=0.022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sirolimus (Drug); cyclosporine or tacrolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year |
1.31; 2.48 | 0.022 sig |
| SECONDARY Time to First Biopsy Confirmed New NMSC Lesion. |
380; 163 | 0.047 sig |
| SECONDARY Number of Lesion Free Subjects |
17; 9 | 0.015 sig |
| SECONDARY Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) |
67; 69; 33; 31 | 0.799 |
| SECONDARY Grade Distribution of NMSC Lesions |
5; 17; 9; 14; 1; 1 | 0.014 sig |
| SECONDARY Number of Recurrent NMSC Lesions Per Subject-year |
0.107; 0.134 | 0.748 |
| SECONDARY Subjects Reporting Incidence of Metastatic Disease Related to NMSC. |
1; 3 | 0.425 |
| SECONDARY Death Due to NMSC |
0; 0 | — |
| SECONDARY Number of Subjects Who Discontinue Assigned Therapy |
31; 23 | — |
| SECONDARY Nankivell-Calculated Glomerular Filtration Rate (GFR) |
72.49; 68.42 | 0.604 |
| SECONDARY Serum Creatinine Level |
139.35; 135.23 | 0.672 |
| SECONDARY Number of Participants That Died |
1; 1 | 0.999 |
| SECONDARY Graft Survival Measured by Graft Loss |
2; 1 | 0.588 |
| SECONDARY Number of Subjects With Biopsy-Confirmed Acute Rejection |
0; 1 | 0.999 |
| SECONDARY Spot Urine Protein:Creatinine Ratio |
0.14; 0.12 | 0.030 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00129961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.