A multi-centre, open, prospective, randomized, parallel-group, 24-month study to compare the outcome of receiving continued immunosuppression versus stopping immunosuppression at 6 months to safely prevent human leukocyte antigen (HLA) sensitization in patients with late renal graft failure

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506879-98-00

Acronym

PREVSENSI

Enrollment

202

Registered

2023-11-10

Start date

2024-01-22

Completion date

Unknown

Last updated

2024-09-25

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

Conditions

Renal transplantation

Brief summary

The primary variable will be the difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).

Interventions

DRUGPrograf 1 mg Cápsulas duras

DRUGSandimmun Neoral 50 mg cápsulas blandas

DRUGAdvagraf 1 mg prolonged-release hard capsules

DRUGConferoport 0

DRUG5 mg cápsulas duras de liberación prolongada EFG

DRUGAdvagraf 5 mg prolonged-release hard capsules

DRUGConferoport 3 mg cápsulas duras de liberación prolongada EFG

DRUGConferoport 2 mg cápsulas duras de liberación prolongada

DRUGPrograf 0

DRUG5 mg Cápsulas duras

DRUGAdoport 1 mg cápsulas duras EFG

DRUGAdoport 2 mg cápsulas duras

DRUGAdvagraf 3 mg prolonged-release hard capsules

DRUGAdoport 5 mg cápsulas duras EFG

DRUGEnvarsus 0.75 mg prolonged-release tablets

DRUGSandimmun Neoral 25 mg cápsulas blandas

DRUGEnvarsus 1 mg prolonged-release tablets

DRUGConferoport 1 mg cápsulas duras de liberación prolongada EFG

DRUGSandimmun Neoral 100 mg cápsulas blandas

DRUGEnvarsus 4 mg prolonged-release tablets

DRUGAdoport 0

DRUG5 mg cápsulas duras EFG

DRUGConferoport 5 mg cápsulas duras de liberación prolongada EFG

DRUGAdvagraf 0.5 mg prolonged-release hard capsules

DRUGPrograf 5 mg Cápsulas duras

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary variable will be the difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026