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Kidney Transplant Failure and RejectionPhase 4BIOIMMUNNCT03465397

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

A Phase 4 study testing biomarkers driven immunosuppressive therapy in people with Kidney Transplant Failure and Rejection, run by ORIOL BESTARD at 6 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant Failure and Rejection
What is being tested?
biomarkers driven immunosuppressive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
6 sitesSpain
Study dates
10 Nov 2017to Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 19Show fewer
  • 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.
  • Patients with known hypersensitivity to any of the drugs used in this study.
  • Patients who have received any investigational drug in the 30 days prior to their inclusion in this study.
  • 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.
  • Patients who are legally detained in an official institution.

Trial locations and contacts

6 sites in 1 country.

CAROLINA POLO, PhD contact

+34 93 260 73 85

cpolo@idibell.cat

EULÀLIA MOLINAS, Pharmacist contact

+34 93 260 73 85

emolinas@idibell.cat

6 sites in 1 country

Spain6 sites, 6 recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona

    RICARDO LAUZURICA, DR, rlauzurica.germanstrias@gencat.cat

    LAURA CAÑAS, DR, laucanyas78@hotmail.com

    Recruiting

  • Fundació Puigvert

    Barcelona

    LLUIS GUIRADO, DR, LGuirado@fundacio-puigvert.es

    CARME FACUNDO, DR, CFacundo@fundacio-puigvert.es

    Recruiting

  • Hospital Clinic

    Barcelona

    FRITZ DIEKMANN, DR, FDIEKMAN@clinic.cat

    FRITZ DIEKMANN, DR

    Not yet recruiting

  • Hospital Del Mar

    Barcelona

    MARTA CRESPO, DR, MCrespo@parcdesalutmar.cat

    MARTA CRESPO, DR

    Recruiting

  • Hospital Universitari Vall D'Hebrón

    Barcelona

    FRANCESC MORESO, DR

    fjmoreso@vhebron.net

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Carolina Polo, PhD, +34 93 260 73 85, cpolo@idibell.cat

    Eulàlia Molinas, +34 93 260 73 85, emolinas@idibell.cat

    Recruiting

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
biomarkers driven immunosuppressive therapy
Medical subject headings
Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biomarkers driven immunosuppressive therapyDiagnostic test

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

Study groups in NCT03465397
Study groupRoleWhat they receive
experimentalExperimentalBiomarkers driven immunosuppressive therapy: the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk
Receives: Diagnostic Test: biomarkers driven immunosuppressive therapy
controlNo interventionAll patients receive the usual triple immunosuppressive treatment, without depending on the results of any biomarker.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (11)

  1. mortality

    Mortality from any cause

    Measured: 24 months

  2. kidney graft loss

    Loss of kidney graft

    Measured: 24 months

  3. Subclinical and chronic rejection

    Incidence and severity of subclinical and chronic rejection (according to protocol biopsies)

    Measured: at 3 and 24 months

  4. Opportunistic infections

    Incidence of opportunistic infections

    Measured: 24 months

  5. Metabolopathies

    Incidence of metabolopathies derived from the treatment (diabetes mellitus, dyslipidemia and HT)

    Measured: 24 months

  6. Cardiovascular Events

    Incidence of cardiovascular events

    Measured: 24 months

  7. Malignancy

    Incidence of malignancy (cutaneous and non-cutaneous cancer)

    Measured: 24 months

  8. Treatment maintenance

    Proportion of patients who maintain the treatment according to the protocol at the end of the trial.

    Measured: 24 months

  9. Immune Response Changes

    Changes in the immune response at 24 months according to the biomarkers (urine cytokines CXCL9 and CXCL10, test KSORT, ELISPOT)

    Measured: 24 months

  10. Economic cost

    Study of the economic cost

    Measured: 24 months

  11. Serious adverse reactions

    serious adverse events with a possible causal relationship with the immunosuppressive treatment)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2018
  2. Study start10 Nov 2017
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter open clinical trial, randomized, stratified by age, parallel groups
Masking
None (open label)
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03465397
Sponsor's protocol ID
BIOIMMUN
Acronym
BIOIMMUN
Status last verified
Jan 2021
First submitted
4 Jan 2018
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biomarkers driven immunosuppressive therapy in people with Kidney Transplant Failure and Rejection, run by ORIOL BESTARD at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact CAROLINA POLO, PhD (+34 93 260 73 85, cpolo@idibell.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03465397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.

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