The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (\> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months. The main question this study aims to answer is: Does maintaining long-term immunosuppression in patients with a late renal graft failure (\> 3 months) safely reduce the risk of HLA sensitization? To answer this question, patients will be assigned to a control arm or investigational arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months. * Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years. Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
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
CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.
Hospital Universitario Vall D'Hebron
Barcelona, Spain
RECRUITINGDegree of HLA sensitization
The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
Time frame: 2 years
Mortality for any reason
The difference between the two treatment arms at 2-years on mortality for any reason
Time frame: 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
Time frame: 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
Time frame: 2 years
Percentage of patients transplanted
The difference between the two treatment arms at 2-years on percentage of patients transplanted
Time frame: 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
Time frame: 2 years
Incidence of infection
The difference between the two treatment arms at 2-years on incidence of infection
Time frame: 2 years
Incidence of cardiovascular events
The difference between the two treatment arms at 2-years on incidence of cardiovascular events
Time frame: 2 years
Incidence of cancer
The difference between the two treatment arms at 2-years on incidence of cancer
Time frame: 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
Time frame: 2 years
Erythropoietin resistance index
The difference between the two treatment arms at 2-years on erythropoietin resistance index
Time frame: 2 years
Residual renal function
The difference between the two treatment arms at 2-years on residual renal function
Time frame: 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
Time frame: 2 years
Adverse events
The difference in the incidence of adverse events (AE) in the two treatment arms
Time frame: 2 years
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