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IMLIFIDASE IN LIVING DONOR RENAL TRANSPLANTATION: HIGHLY SENSITIZED RECIPIENTS
EU CTIS ID: 2024-513607-14-00
What this study is testing
To evaluate the ability of Imlifidase treatment to achieve a negative virtual crossmatch in patients with available live donor kidney
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •Highly sensitized (cPRA ≥ 50%) kidney transplant candidates between 18 and 65 years.
- • Low probability to get a transplant in a kidney exchange program (KEP) from a living donor.
- • Included in the living donor program, with an accepted potential living donor.
- • Donor and recipient must meet the eligibility criteria for donation and kidney transplantation respectively at the Hospital Clinic of Barcelona and the national guidelines.
- • Presence of donor-specific antibody/crossmatch positive (DSA/FC-XM+) non-HLA identical donor. o at least one DSA with MFI >3.000. o and DSA MFI <10.000 (in serum samples diluted 1/64). o and maximum two Class II DSAs. o and maximum 17 points in Jordan RIS Score (DSA 2500-5000: 2 points; DSA MFI 5001-10000: 5 points; DSA MFI > 10000: 10 points)
- • Women of childbearing age must take contraceptive measures because imlifidase is not recommended during pregnancy.
You likely can't join if
- Known contraindications for therapy with IVIG, Rituximab, plasma exchange (PLEX) or imlifidase.
- Subjects with active CMV or EBV infection as defined by positive PCR.
- Subjects with a known history of previous myocardial infarction within one year of screening.
- Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
- Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
- Subjects with Protein C and Protein S deficiency.
See the full eligibility criteria
Who can join
- •Highly sensitized (cPRA ≥ 50%) kidney transplant candidates between 18 and 65 years.
- • Low probability to get a transplant in a kidney exchange program (KEP) from a living donor.
- • Included in the living donor program, with an accepted potential living donor.
- • Donor and recipient must meet the eligibility criteria for donation and kidney transplantation respectively at the Hospital Clinic of Barcelona and the national guidelines.
- • Presence of donor-specific antibody/crossmatch positive (DSA/FC-XM+) non-HLA identical donor. o at least one DSA with MFI >3.000. o and DSA MFI <10.000 (in serum samples diluted 1/64). o and maximum two Class II DSAs. o and maximum 17 points in Jordan RIS Score (DSA 2500-5000: 2 points; DSA MFI 5001-10000: 5 points; DSA MFI > 10000: 10 points)
- • Women of childbearing age must take contraceptive measures because imlifidase is not recommended during pregnancy.
- • Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
What rules you out
- Known contraindications for therapy with IVIG, Rituximab, plasma exchange (PLEX) or imlifidase.
- Subjects with active CMV or EBV infection as defined by positive PCR.
- Subjects with a known history of previous myocardial infarction within one year of screening.
- Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
- Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
- Subjects with Protein C and Protein S deficiency.
- Pregnant and lactating women
- Current diagnosis or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP.
- Known allergy to Imlifidase or excipient of the drug preparation
- Recipients of Deceased Donors (DBD, Extended Criteria Donors (ECD) or DCD).
- A positive Complement-Dependent Cytotoxicity (CDC) Crossmatch against the living donor.
- HIV-positive subjects.
- Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
- Subjects with active TB.
- Subjects with selective IgA deficiency, those who have known anti-IgA antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material.
- Subjects who have received or for whom multiple organ transplants are planned.
- A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3xupper limit.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.