A Phase 4 interventional study of biomarkers driven immunosuppressive therapy in Kidney Transplant Failure and Rejection, sponsored by ORIOL BESTARD. Status unknown at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by ORIOL BESTARD · Phase 4, Interventional, and Prevention
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.
Exclusion Criteria:
Patients with any of the following basic renal diseases:
Biomarkers driven immunosuppressive therapy: the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk
Diagnostic Test: biomarkers driven immunosuppressive therapy
All patients receive the usual triple immunosuppressive treatment, without depending on the results of any biomarker.
the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk
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
Proportion 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
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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