| August 23, 2005 |
| February 6, 2009 |
| April 2004 |
| March 2014 (final data collection date for primary outcome measure) |
| To assess the incidence of new squamous cell carcinoma in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ] |
| To assess the incidence of new squamous cell carcinoma in kidney transplant recipients. |
| Complete list of historical versions of study NCT00133887 on ClinicalTrials.gov Archive Site |
- To assess the incidence of other non skin cancer in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
- To assess the graft survival [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
- To assess the tolerance of rapamycin [ Time Frame: during 5 years ] [ Designated as safety issue: Yes ]
|
- To assess the incidence of other non skin cancer in kidney transplant recipients.
- To assess the graft survival
- To assess the tolerance of rapamycin
|
| |
| TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients |
| Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-Label Study of Rapamycin vs Calcineurin Inhibitors |
In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
- Skin Cancer
- Kidney Transplantation
|
- Drug: rapamycin
- Drug: ciclosporine
- Drug: tacrolimus
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- Experimental: patients receiving Rapamycin
- Active Comparator: patients receiving anticalcineurin treatment
|
- Aractingi S, Kanitakis J, Euvrard S, Le Danff C, Peguillet I, Khosrotehrani K, Lantz O, Carosella ED. Skin carcinoma arising from donor cells in a kidney transplant recipient. Cancer Res. 2005 Mar 1;65(5):1755-60.
- Togel F, Hu Z, Weiss K, Isaac J, Lange C, Westenfelder C, Stasko T, Brown MD, Carucci JA, Euvrard S, Johnson TM, Sengelmann RD, Stockfleth E, Tope WD, Asselbergs FW, Diercks GF, Hillege HL, van Boven AJ, Janssen WM, Voors AA, de Zeeuw D, de Jong PE, van Veldhuisen DJ, van Gilst WH. Amelioration of Acute Renal Failure by Stem Cell Therapy--Paracrine Secretion Versus Transdifferentiation into Resident Cells: Administered Mesenchymal Stem Cells Protect against Ischemic Acute Renal Failure through Differentiation-Independent Mechanisms. Am J Physiol Renal Physiol E-pub February 15, 2005. J Am Soc Nephrol. 2005 May;16(5):1153-63. No abstract available.
- Martinez JC, Otley CC, Euvrard S, Arpey CJ, Stasko T; International Transplant-Skin Cancer Collaborative. Complications of systemic retinoid therapy in organ transplant recipients with squamous cell carcinoma. Dermatol Surg. 2004 Apr;30(4 Pt 2):662-6.
|
| |
| Recruiting |
| 120 |
|
| March 2014 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors
Exclusion Criteria:
- Other squamous cell carcinomas in the past history
- More than 2 transplantations
- Patients not under calcineurin inhibitors
- Unstable graft function
- Non controlled hyperlipidemia (cholesterol > 7.8 mmol/l or triglycerides > 3.95 mmol/l)
- Leucopenia < 3000/mm3
- Thrombocytopenia < 100,000/mm3
- Liver dysfunction
- Pregnancy
- Allergy to macrolides
|
| Both |
| 18 Years to 80 Years |
| No |
|
|
| France |
| |
| NCT00133887 |
| Sylvie EUVRARD, Hospices Civils de Lyon |
| 2003.333 |
| Hospices Civils de Lyon |
|
| Principal Investigator: |
Sylvie EUVRARD, MD |
Hospices Civils de Lyon |
|
|
| Hospices Civils de Lyon |
| February 2009 |
