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

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ClinicalTrials.gov Identifier: NCT03465397
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Department of Health, Generalitat de Catalunya
Information provided by (Responsible Party):
ORIOL BESTARD, Hospital Universitari de Bellvitge

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

Condition or disease Intervention/treatment Phase
Kidney Transplant Failure and Rejection Diagnostic Test: biomarkers driven immunosuppressive therapy Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter open clinical trial, randomized, stratified by age, parallel groups
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
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
the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk
No Intervention: control
All patients receive the usual triple immunosuppressive treatment, without depending on the results of any biomarker.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. mortality [ Time Frame: 24 months ]
    Mortality from any cause

  2. kidney graft loss [ Time Frame: 24 months ]
    Loss of kidney graft

  3. Subclinical and chronic rejection [ Time Frame: at 3 and 24 months ]
    Incidence and severity of subclinical and chronic rejection (according to protocol biopsies)

  4. Opportunistic infections [ Time Frame: 24 months ]
    Incidence of opportunistic infections

  5. Metabolopathies [ Time Frame: 24 months ]
    Incidence of metabolopathies derived from the treatment (diabetes mellitus, dyslipidemia and HT)

  6. Cardiovascular Events [ Time Frame: 24 months ]
    Incidence of cardiovascular events

  7. Malignancy [ Time Frame: 24 months ]
    Incidence of malignancy (cutaneous and non-cutaneous cancer)

  8. Treatment maintenance [ Time Frame: 24 months ]
    Proportion of patients who maintain the treatment according to the protocol at the end of the trial.

  9. Immune Response Changes [ Time Frame: 24 months ]
    Changes in the immune response at 24 months according to the biomarkers (urine cytokines CXCL9 and CXCL10, test KSORT, ELISPOT)

  10. Economic cost [ Time Frame: 24 months ]
    Study of the economic cost

  11. Serious adverse reactions [ Time Frame: 24 months ]
    serious adverse events with a possible causal relationship with the immunosuppressive treatment)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult men and women (≥18 years).
  2. Receptors of a first kidney transplant from an incompatible HLA living donor (at least 1 mismatch HLA at any antigenic level).
  3. AB0 compatible transplant.
  4. 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®).
  5. Patients who agree to participate in the Trial by signing the Specific Informed Consent of this study.
  6. 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.
  7. 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.
  8. 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:

  1. 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®).
  2. Positive result of Cross Match.
  3. Patients who receive a graft from a cadaver donor.
  4. Identical HLA patients
  5. Patients who have undergone a previous solid organ transplant (including kidney transplant) or who are going to receive another solid organ transplant concomitantly.
  6. Patients with any of the following basic renal diseases:

    • Glomerular primary focal and segmental sclerosis
    • Atypical hemolytic uremic syndrome (aHUS) / thrombotic thrombocytopenic purpura syndrome.
  7. 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.
  8. Patients with infection with the known Human Immunodeficiency Virus (HIV).
  9. Patients with active systemic infection that requires the continued administration of antibiotics.
  10. Patients with any neoplasm except localized skin cancer and who is receiving adequate treatment.
  11. Patients with severe anemia (hemoglobin <6g / dl), leukopenia (WBC <2500 / mm3) and / or thrombocytopenia (platelets <80,000 / mm3).
  12. Patients who are hemodynamically unstable even if they have hemoglobin levels> 6g / dL.
  13. Patients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.
  14. Patients with known hypersensitivity to any of the drugs used in this study.
  15. Patients who have received any investigational drug in the 30 days prior to their inclusion in this study.
  16. Potentially fertile women who do not agree to use reliable contraceptive measures during the trial, who are pregnant, breastfeeding or who present a positive pregnancy test at the time of their inclusion in the study.
  17. Patients who are legally detained in an official institution.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465397


Contacts
Contact: CAROLINA POLO, PhD +34 93 260 73 85 cpolo@idibell.cat
Contact: EULÀLIA MOLINAS, Pharmacist +34 93 260 73 85 emolinas@idibell.cat

Locations
Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Carolina Polo, PhD    +34 93 260 73 85    cpolo@idibell.cat   
Contact: Eulàlia Molinas    +34 93 260 73 85    emolinas@idibell.cat   
Principal Investigator: ORIOL BESTARD, DR         
Sub-Investigator: EDOARDO MELILLI, DR         
Hospital Universitari Germans Trias I Pujol Recruiting
Badalona, Spain
Contact: RICARDO LAUZURICA, DR       rlauzurica.germanstrias@gencat.cat   
Contact: LAURA CAÑAS, DR       laucanyas78@hotmail.com   
Principal Investigator: RICARDO LAUZURICA         
Principal Investigator: LAURA CAÑAS         
Fundació Puigvert Recruiting
Barcelona, Spain
Contact: LLUIS GUIRADO, DR       LGuirado@fundacio-puigvert.es   
Contact: CARME FACUNDO, DR       CFacundo@fundacio-puigvert.es   
Principal Investigator: LLUIS GUIRADO, DR         
Principal Investigator: CARME FACUNDO, DR         
Hospital Clinic Not yet recruiting
Barcelona, Spain
Contact: FRITZ DIEKMANN, DR       FDIEKMAN@clinic.cat   
Principal Investigator: FRITZ DIEKMANN, DR         
Hospital Del Mar Recruiting
Barcelona, Spain
Contact: MARTA CRESPO, DR       MCrespo@parcdesalutmar.cat   
Principal Investigator: MARTA CRESPO, DR         
Hospital Universitari Vall D'Hebrón Recruiting
Barcelona, Spain
Contact: FRANCESC MORESO, DR         
Contact       fjmoreso@vhebron.net   
Principal Investigator: FRANCESC MORESO, DR         
Sponsors and Collaborators
ORIOL BESTARD
Department of Health, Generalitat de Catalunya

Responsible Party: ORIOL BESTARD, Head of Transplant Unit, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03465397     History of Changes
Other Study ID Numbers: BIOIMMUN
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs