NL-OMON49228
Not yet recruiting
Not Applicable
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 - BIOIMM
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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