This is a clinical trial comparing the immunosuppressive treatment determined according to two biomarkers, donor-specific IFN-γ ELISPOT and Mismatch of HLA between donor and recipient, in patients undergoing low immunological risk live donor kidney transplantation
This is a national multicenter clinical trial, controlled, randomized, stratified, parallel groups, and without masking. This is a prospective intervention study in which two strategies for determining immunosuppressive treatment in kidney transplant patients from a live donor with low immunological risk are compared according to solid phase antibody detection techniques (cPRA 0% and isolated negative antigen) and crossmatch by negative cytotoxicity. Patients are randomized in a 1: 1 ratio to receive one of two immunosuppressive treatment strategies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
164
the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital Universitari Germans Trias I Pujol
Badalona, Spain
RECRUITINGFundació Puigvert
Barcelona, Spain
composite
composite variable evaluated at 2 years of follow-up as a proportion of patients who meet any of the following criteria: loss of renal function, incidence of acute clinical rejection confirmed by biopsy (BPAR) and development of dnDSA.
Time frame: 24 months
mortality
Mortality from any cause
Time frame: 24 months
kidney graft loss
Loss of kidney graft
Time frame: 24 months
Subclinical and chronic rejection
Incidence and severity of subclinical and chronic rejection (according to protocol biopsies)
Time frame: at 3 and 24 months
Opportunistic infections
Incidence of opportunistic infections
Time frame: 24 months
Metabolopathies
Incidence of metabolopathies derived from the treatment (diabetes mellitus, dyslipidemia and HT)
Time frame: 24 months
Cardiovascular Events
Incidence of cardiovascular events
Time frame: 24 months
Malignancy
Incidence of malignancy (cutaneous and non-cutaneous cancer)
Time frame: 24 months
Treatment maintenance
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Hospital Clinic
Barcelona, Spain
NOT_YET_RECRUITINGHospital Del Mar
Barcelona, Spain
RECRUITINGHospital Universitari Vall D'Hebrón
Barcelona, Spain
RECRUITINGProportion of patients who maintain the treatment according to the protocol at the end of the trial.
Time frame: 24 months
Immune Response Changes
Changes in the immune response at 24 months according to the biomarkers (urine cytokines CXCL9 and CXCL10, test KSORT, ELISPOT)
Time frame: 24 months
Economic cost
Study of the economic cost
Time frame: 24 months
Serious adverse reactions
serious adverse events with a possible causal relationship with the immunosuppressive treatment)
Time frame: 24 months