Multicenter, Randomized Study to Evaluate the Effectiveness of the Individualization of the Immunological Risk Based on Biomarkers (Disparity of HLA and IFN-γ ELISPOT) to Optimize Immunosuppressor Treatment in Living-donor Renal Recipients

ORIOL BESTARD6 sites in 1 country164 target enrollmentNovember 10, 2017

ConditionsKidney Transplant Failure and Rejection

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Kidney Transplant Failure and Rejection
Sponsor: ORIOL BESTARD
Enrollment: 164
Locations: 6
Primary Endpoint: composite
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 10, 2017

End Date

November 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ORIOL BESTARD

Responsible Party

Sponsor Investigator

Principal Investigator

ORIOL BESTARD

Head of Transplant Unit

Hospital Universitari de Bellvitge

Eligibility Criteria

Inclusion Criteria

•Adult men and women (≥18 years).
•Receptors of a first kidney transplant from an incompatible HLA living donor (at least 1 mismatch HLA at any antigenic level).
•AB0 compatible transplant.
•Patients with a calculated PRA of 0% by solid phase technique and absence of anti-HLA class I and class II antibodies by single antigen test (Luminex®).
•Patients who agree to participate in the Trial by signing the Specific Informed Consent of this study.
•Potentially fertile women should use high reliability contraceptive methods (Pearl-Index \<1) in order to avoid pregnancy during the entire duration of the study and up to 6 weeks after the end of their treatment with Mycophenolate Mofetil (MMF). Potentially Fertile Women include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or who is not post-menopausal (defined as amenorrhea ≥ 12 consecutive months, or women who are receiving hormone replacement therapy with a documented level of follicle stimulating hormone (FSH)\> 35 mlU / ml). Potentially fertile women must have a pregnancy test with a negative result in the 72 hours prior to the start of the trial.
•Sexually active males (including vasectomized males) who are being treated with MMF must accept the use of barrier contraceptive methods during MMF treatment and for 90 days thereafter. Potentially fertile partners of these patients should use a reliable contraceptive method during the same period, in order to minimize the risk of pregnancy.
•Patients must agree not to donate blood during treatment with MMF and during the 6 subsequent weeks. Males should not make a sperm donation during MMF treatment and up to 90 days after completion.

Exclusion Criteria

•Patients with a calculated PRA higher than 0% per solid phase and / or anti-HLA class I and / or class II antibodies detectable by single antigen test (Luminex®).
•Positive result of Cross Match.
•Patients who receive a graft from a cadaver donor.
•Identical HLA patients
•Patients who have undergone a previous solid organ transplant (including kidney transplant) or who are going to receive another solid organ transplant concomitantly.
•Patients with any of the following basic renal diseases:
•Glomerular primary focal and segmental sclerosis
•Atypical hemolytic uremic syndrome (aHUS) / thrombotic thrombocytopenic purpura syndrome.
•Patients with chronic infection with Hepatitis B virus (HBV) and / or active infection with Hepatitis C virus (positive PCR result) at the time of transplant.
•Patients with infection with the known Human Immunodeficiency Virus (HIV).

Outcomes

Primary Outcomes

composite

Time Frame: 24 months

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.