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Intérêt de la rapamicine (Rapamune(R)) pour la prévention secondaire des cancers cutanés chez les transplantés rénaux ayant présentant plus d'un Carcinome Spinocellaire.

Intérêt de la rapamicine (Rapamune(R)) pour la prévention secondaire des cancers cutanés chez les transplantés rénaux ayant présentant plus d'un Carcinome Spinocellaire.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004509-27-BE
Enrollment
128
Registered
2006-02-08
Start date
2006-04-21
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To evaluate the impact of two immunosuppressive regimens on the incidence of skin cancers among patients who have had previously a first spinocellulaire skin cancer after transplantation

Interventions

Trade Name: Neoral 50 mg Product Name: Neoral Pharmaceutical Form: Capsule* INN or Proposed INN: cyclosporine Concentration unit: mg milligram(s) Concentration number: 50- Trade Name: rapamune 1mg Pr

Sponsors

Cliniques Hopitaux Universitaires NANTES
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patient aged 18 year old or more with kidney transplant with immunusuppressive treatment with calcineurines inhibitor recurrence of spinocellular carcinoma Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patient aged less than 18year old métastatic carcinoma previous treatment with rapamycine pregnant woman

Design outcomes

Primary

MeasureTime frame
Main Objective: Rapamycine replacement of calcineurines inhibitor could reduce the risk of a new skin cancer by 40% or more while preserving graft function;Secondary Objective: ;Primary end point(s): to analyse the annual incidence of spinocellular carcinoma

Countries

Belgium, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026