Individualization of the Immunological Risk Based on Selective Biomarkers in Living-donor Renal Recipients

NCT03465397 | Unknown Phase 4

• 1 other identifier: BIOIMMUN
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 6

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

Conditions

Kidney Transplant Failure and Rejection

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (11)

• mortality

  24 months

• kidney graft loss

  24 months

• Subclinical and chronic rejection

  at 3 and 24 months

• Opportunistic infections

  24 months

• Metabolopathies

  24 months

Study Arms (2)

experimental

EXPERIMENTAL

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

control

NO INTERVENTION

All patients receive the usual triple immunosuppressive treatment, without depending on the results of any biomarker.

Interventions

biomarkers driven immunosuppressive therapy DIAGNOSTIC_TEST

the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients with active systemic infection that requires the continued administration of antibiotics.
• Patients with any neoplasm except localized skin cancer and who is receiving adequate treatment.
• Patients with severe anemia (hemoglobin \<6g / dl), leukopenia (WBC \<2500 / mm3) and / or thrombocytopenia (platelets \<80,000 / mm3).
• Patients who are hemodynamically unstable even if they have hemoglobin levels\> 6g / dL.
• Patients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.

Sponsors & Collaborators

• ORIOL BESTARD: lead
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (6)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

RECRUITING

Fundació Puigvert

Barcelona, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

NOT YET RECRUITING

Hospital Del Mar

Barcelona, Spain

RECRUITING

Hospital Universitari Vall D'Hebrón

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

CAROLINA POLO, PhD

CONTACT

+34 93 260 73 85; cpolo@idibell.cat

EULÀLIA MOLINAS, Pharmacist

CONTACT

+34 93 260 73 85; emolinas@idibell.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Transplant Unit

Model Details: Multicenter open clinical trial, randomized, stratified by age, parallel groups

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: March 14, 2018
• Study Start: November 10, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

ES (6)