2024-513607-14-00已完成2 期
IMLIFIDASE IN LIVING DONOR RENAL TRANSPLANTATION: HIGHLY SENSITIZED RECIPIENTS (LIVEDES STUDY)
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月22日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses).
研究概览
简要总结
To evaluate the ability of Imlifidase treatment to achieve a negative virtual crossmatch in patients with available live donor kidney
详细描述
The patients between 18 and 65 years will be flow cytometry crossmatch (FC-XM) positive against an available living donor. The imlifidase treatment will turn the crossmatch test negative prior to transplantation. A second dose of imlifidase can be given within 24 hours if the first dose is considered not to have sufficient effect. If a second dose is given, a confirmatory FCXM test will be performed pre-second imlifidase dosing and between 2-6 hours following the second dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Imlifidase In Living Donor Renal Transplantation: Highly Sensitized Recipients
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses).
Proportion of patients with conversion of a positive virtual crossmatch to negative within 6 hours after imlifidase treatment (up to two doses).
次要结局
- To evaluate flow cytometry T-cell crossmatch conversion within 24 hours of imlifidase treatment, requirement of a second dose of imlifidase.
- To evaluate the rebound of preexisting donor specific antibodies (DSA) (difference between MFI of each DSA daily - until D+14 - compared to pre-imlifidase administration)
- To evaluate the appearance of de novo DSAs (any DSA no present in pre-transplant or historical) daily - until D+14. To be considered positive the bead MFI should be over 750 and to be above the bead specific threshold related to the lowest bead of the same locus.
- HLA/DSA antibody levels at several time points between pre-dose imlifidase and 2 weeks, and at 1, 3 and 6 months and 1 year after imlifidase treatment
- Renal function at several time points between 24 hours and 2 weeks and at 1, 3 and 6 months and 1 year after transplantation as assessed by estimated glomerular filtration rate (eGFR) and serum/plasma creatinine levels
- To evaluate patient survival 1 year after transplantation
- To evaluate the graft survival at 12 months (both overall and death-censored analysis)
- To evaluate the incidence of acute allograft rejection within 12 months (overall and stratified by type: cell mediated rejection or antibody-mediated rejection)
- To evaluate safety of Imlifidase treatment with regards to infusion related reactions occurring within 48 hours of Imlifidase infusion
- To evaluate the adverse events within 30 days after transplantation
- To evaluate to severe or serious infections (that required hospitalization) within 30 days after transplantion, at 6 and 12 months
- To evaluate safety of Imlifidase treatment with regards to reported serious adverse events (SAEs)
研究者
Fritz Diekmann
Scientific
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
研究点 (1)
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