Multicentric, randomized trial to evaluate the efficacy of baseline Immune-risk stratification based on selective Biomarkers (HLA Eplet mismatching and donor-specific IFN-γ ELISPOT) to optimize Immunosuppressive therapy in Living-kidney transplant patients

• Conditions: 10038365; preventing rejection kidney after transplant; nier transplantatie; immunosuppression after kidney transplant

• Registration Number: NL-OMON49228
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

• Male or female patients >= 18 years old.
• Recipients of a primary kidney transplant from a living non-HLA identical
donor (at least 1 HLA missmatch).
• Compatible ABO transplant.
• Patients with a calculated PRA (cPRA) <= 75% by solid-phase assays and
absence of donor-specific anti-HLA antibodies (DSA) against class I and class
II in an actual or historical screened sera.
• Written informed consent must be obtained before any assessment is performed.
• Women of child-bearing potential must use highly reliable 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). Women of child-bearing potential 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). Women
of child-bearing potential must have a pregnancy test with a negative result in
the 72 hours prior to the start of the trial.
• Sexually active males (also vasectomized men) receiving MMF must use a condom
during MMF treatment and the following 90 days. Fertile partners must use an
effective method of contraception.
• Patients must agree not to donate blood during MMF treatment and for 6 weeks
thereafter. Males should not donate sperm during MMF treatment and up to 90
days after completion.

Exclusion Criteria

• Patients with a calculated PRA (cPRA) > 75% by solid-phase assays and/or
presence of donor-specific anti-HLA antibodies (DSA) against class I and class
II in an actual or historical screened sera.
• Positive pre-transplant Cross Match test (either CDC or FCXM).
• Recipients of a deceased donors.
• HLA identical subjects
• Multi-organ transplant recipients or prior kidney transplant.
• Patients with one of the following diseases:
o Primary focal and segmental glomerulosclerosis
o Atypical Uremic Hemolytic Syndrome (aHUS) / Thrombotic Thrombocytopenic
Purpura.
• Patients with active infection with Hepatitis B virus (HBV) and / or active
infection with Hepatitis C virus (positive PCR result) at the time of
transplant.
• Patients with known HIV disease.
• Patients with active systemic infection that requires continuing antibiotic
treatment.
• Patients with malignancy of any organ system, with the exception of localized
excised skin cancer.
• Patients with severe anemia (hemoglobin <6g/dl), leukopenia (WBC <2500/mm3)
and/or thrombocitopenia (platelet count <80.000/mm3).
• Hemodynamically unstable patients, 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.
• Women of child-bearing potential who do not agree to use reliable
contraceptive measures during the trial, who are pregnant, breast-feeding or
presents a positive pregnancy test at the time of inclusion in the study.
• Patients who are legally detained in an official institution.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Composite end-point evaluated at 2 years of follow-up as a proportion of<br /><br>patients that meet any of the following criteria: loss of renal function,<br /><br>incidence of acute clinical rejection confirmed by biopsy (BPAR) and<br /><br>development of dnDSA.</p><br>