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Clinical Trial Details

Trial ID: L1323
Source ID: NCT06676696
Associated Drug: Continue Low Dose Calcineurin Inhibitor (Cni)
Title: 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
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Renal Failure , Chronic|Graft Failure|Graft Rejection|Allograft|Renal Failure Chronic Requiring Dialysis
Interventions: DRUG: Continue low dose calcineurin inhibitor (CNI)|DRUG: Calcineurin inhibitor withdrawal at 6 months
Outcome Measures: Primary: Degree of HLA sensitization, The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%)., 2 years | Secondary: Mortality for any reason, The difference between the two treatment arms at 2-years on mortality for any reason, 2 years|Days of hospitalization for any reason, The difference between the two treatment arms at 2-years on days of hospitalization for any reason, 2 years|Percentage of patients effectively relisted during follow-up, The difference between the two treatment arms at 2-years on percentage of patients effectively relisted during follow-up, 2 years|Percentage of patients transplanted, The difference between the two treatment arms at 2-years on percentage of patients transplanted, 2 years|Percentage of patients delisted for any reason, The difference between the two treatment arms at 2-years on percentage of patients delisted for any reason, 2 years|Incidence of infection, The difference between the two treatment arms at 2-years on incidence of infection, 2 years|Incidence of cardiovascular events, The difference between the two treatment arms at 2-years on incidence of cardiovascular events, 2 years|Incidence of cancer, The difference between the two treatment arms at 2-years on incidence of cancer, 2 years|Incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft, The difference between the two treatment arms at 2-years incidence of graft-intolerance syndrome requiring graft nephrectomy or percutaneous embolization of the non-functioning graft, 2 years|Erythropoietin resistance index, The difference between the two treatment arms at 2-years on erythropoietin resistance index, 2 years|Residual renal function, The difference between the two treatment arms at 2-years on residual renal function, 2 years|Number of circulating memory B-cells, The difference between the two treatment arms at 2-years on number of circulating memory B-cells, 2 years|Adverse events, The difference in the incidence of adverse events (AE) in the two treatment arms, 2 years
Sponsor/Collaborators: Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 202
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-22
Completion Date: 2028-01-31
Results First Posted:
Last Update Posted: 2024-11-06
Locations: Hospital Universitario Vall D'Hebron, Barcelona, 0835, Spain
URL: https://clinicaltrials.gov/show/NCT06676696