Efficacité de la rapamycine dans la prévention secondaire des cancers cutanés chez les transplantés rénaux. Etude ouverte randomisée Rapamycine vs anticalcineurines

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004947-23-BE

Enrollment

206

Registered

2006-02-08

Start date

2006-02-22

Completion date

Unknown

Last updated

2024-12-03

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 imnosupressive regimens on the incidence of skin cancers among patients who has a first spinocellular skin cancer after renal transplantation

Interventions

Trade Name: neoral 50MG Product Name: Neoral Pharmaceutical Form: Capsule* INN or Proposed INN: cyclosporine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient aged 18 year old or more with kidney transplant with immunosuppressive 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 les tha 18 year old metastatic carcinoma previous treatment with rapamycine pregnant woman

Design outcomes

Primary

Measure	Time frame
Main Objective: Rapapmycine replacement of calcineurines inhibitor could reduce the risk of a new kin 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