2022-502007-30-00招募中3 期
INduction in Sensitized kidney Transplant recipients without pre-Existing donor-specific AntiboDies: a randomized multicentre trial between a lymphocyte depleting and basiliximab (INSTEAD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 16
- 主要终点
- Incidence of BPAR (treated suspicious TCMR and confirmed TCMR with grade ≥ 1 and ABMR) in rATG and basiliximab groups during the first post-transplantation year, determined after blind central reading according to Banff 2019 classification
研究概览
简要总结
Demonstrate that rATG is more efficient than basiliximab to prevent biopsy-proven acute rejection (BPAR) during the first post-transplantation year in sensitized KTR without pre-existing DSAs
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up assessments and visits (D10 to M36)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18-79
- •At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000
- •Graft incompatibility rate (TGI) < 85%
- •Ability for participant to understand the nature and objectives of the study; to comply with the requirements of the study
- •Written informed consent obtained from the participant
- •Participants covered by or entitled to social security
排除标准
- •DSA (positive virtual crossmatch with MFI threshold at 1000)
- •History of lymphoma
- •Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal
- •Known hypersensitivity or contra-indication to Thymoglobulin® (rATG) or Simulect® (basiliximab) including the product excipients
- •Contra-indication to tacrolimus, mycophenolic acid and steroids
- •Pregnant or breastfeeding woman, or woman of childbearing potential not using an effective method of contraception, or having a desire to conceive, within 12 months of transplantation
- •Patient under judicial protection, deprivation of liberty
- •Participation in another interventional research with an investigational drug or medical device
- •Combined transplantation
- •Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)
- •Incompatible ABO transplantation
- •Leukopenia lower than 3000/mm3
- •Thrombocytopenia (platelets < 50G/L)
- •Donor EBV Positive / Recipient EBV Negative
- •Active HIV infection (positive viral charge)
- •History of solid cancer (< 2 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma)
结局指标
主要结局
Incidence of BPAR (treated suspicious TCMR and confirmed TCMR with grade ≥ 1 and ABMR) in rATG and basiliximab groups during the first post-transplantation year, determined after blind central reading according to Banff 2019 classification
Incidence of BPAR (treated suspicious TCMR and confirmed TCMR with grade ≥ 1 and ABMR) in rATG and basiliximab groups during the first post-transplantation year, determined after blind central reading according to Banff 2019 classification
次要结局
- Incidence of BPAR in rATG and basiliximab groups at year 3
- Incidence of composite criteria including BPAR, death and graft loss (retransplantation or dialysis) at year 3.
- Incidence of confirmed TCMR and ABMR in rATG and basiliximab groups at year 1 and 3.
- Incidence of de novo DSA in rATG and basiliximab groups at year 1 and 3
- Incidence of CMV viremia, CMV disease, BKv viremia and BKv nephropathy in rATG and basiliximab groups at year 1 and 3
- Estimated glomerular filtration rate (eGFR) according to MDRD formula and proteinuria/creatinuria ratio in rATG and basiliximab groups at day 10, month 1, month 3 and 6, year 1, year 2 and 3
- Incidence of primary and secondary outcomes (1 to 6) in subgroups defined by rank of transplantation
- Health-Economics endpoints: a) Incremental Cost Utility Ratio (ICUR) estimating the “cost per QALY gained”, at 12 months, from the French Healthcare Insurance perspective, of rATG in comparison to basiliximab. b) Incremental Cost Effectiveness Ratio (ICER) estimating the “cost per prevented BPAR” at 12 months, from the French Healthcare Insurance perspective, of rATG in comparison to basiliximab.
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (16)
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