NCT06676696View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

January 22, 2024

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Renal Failure , ChronicGraft FailureGraft RejectionAllograftRenal Failure Chronic Requiring Dialysis
Interventions
DRUG

Continue low dose calcineurin inhibitor (CNI)

CNI dose (tacrolimus or cyclosporine) will be adjusted to maintain low tacrolimus or cyclosporine whole blood trough levels from month 3 to month 24 or End of Study

DRUG

Calcineurin inhibitor withdrawal at 6 months

CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.

Trial Locations (1)

0835

RECRUITING

Hospital Universitario Vall D'Hebron, Barcelona

All Listed Sponsors
lead

Hospital Universitari Vall d'Hebron Research Institute

OTHER