Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Frequency of TFH cells and their activation markers
研究概览
简要总结
Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring.
Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft.
The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated.
The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECP treatment decision based on transplant team habits (care management)
- •Age ≥ 18 years
- •Affiliation to a French social security scheme
- •Kidney transplant at least 6 months prior to inclusion
- •cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:
- •allograft glomerulopathy (cg>0, and maximum score cg2) or intimal fibrosis
- •C4d positive or ptc+g greater than or equal to 2
- •Presence of Donor Specific Antibody (DSA)
- •Interstitial Fibrosis and Tubular Atrophy (IFTA) less than or equal to 2
- •Glomerular filtration rate > 30 mL/min/1.73 m2
- •Signed informed consent to participate in the study
排除标准
- •Active infection or infection with hepatitis B, C or HIV virus
- •Pregnant, breastfeeding or parturient woman
- •Person deprived of liberty by judicial or administrative decision
- •Person receiving psychiatric care under duress
- •Person subject to legal protection
- •Person out of state to express consent
研究组 & 干预措施
Extracorporeal phototherapy
干预措施: Extracorporeal phototherapy (Other)
结局指标
主要结局
Frequency of TFH cells and their activation markers
时间窗: From the 1st session of ECP to 1 year after the 1st session
Variation in the frequency of TFH cells and their activation markers under treatment.
次要结局
- Concentration of circulating B-cell populations(From the 1st session of ECP to 1 year after the 1st session)
- Concentration of pro and anti-inflammatory cytokines(From the 1st session of ECP to 1 year after the 1st session)
- Measurement of genetic markers in TFH cells(At 1 week of the 1st session of ECP and at 3 month after the 1st session)
- Subsequent ECP response in patients with cABMR(3 months of treatment per ECP)
- Comparison of clinical data of patients(From the 1st session of ECP to 1 year after the 1st session)
- Comparison of biological data of patients(From the 1st session of ECP to 1 year after the 1st session)