EUCTR2013-002825-52-DE进行中（未招募）不适用
Single-center, open-label, single-arm Phase IIa study in kidney transplant patients with acute T-cell-mediated rejection in renal transplant according to Banff criteria (class IA and IB) without (stage I) or with (stage II) deterioration of graft function for detecting the effectiveness of treatment with canakinumab regarding the regression of infiltrates in the graft biopsy.
Medizinische Hochschule Hannover0 个研究点开始时间: 2013年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 Male or female patients aged at least 18 years at the time of study inclusion
- •2 Kidney transplant within the last 14 months
- •3 Evidence of acute cellular tubulointerstitial rejection in kidney transplant according to Banff criteria (grade IA or IB ), which has been detected in a protocol or indication biopsy, without evidence of more than 20 CD20-positive B cells per high power field in the infiltrate and without evidence glomerulitis or capillaritis
- •4 C4d and SV40 negativity in the biopsy
- •5 eGFR = 30 ml/min/1,73 m2 calculated by MDRD formula before diagnosis of rejection
- •6 In female patients of childbearing potential existence of a negative pregnancy test and consent to a highly effective method of contraception (Pearl Index < 1, i.e., hormonal implants, injectables, oral combination contraceptives, hormonal intrauterine devices, history of two-sided sterilization or oophorectomy, vasectomy of the partner, sexual abstinence, exclusively female sexual partners)
- •7 In male patients consent to a highly effective method of contraception (Pearl Index < 1, i.e., history of vasectomy, sexual abstinence, only male sexual partners; hormonal implants, injectables, oral combination contraceptives, hormonal intrauterine devices, history of sterilization or bilateral oophorectomy of the female partner with childbearing potential)
- •8 Written consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1 Known contraindications or intolerance of canakinumab or concomitant medication
- •2 Administration of canakinumab within 14 months of study entry
- •3 Administration of another biologicals (eg, rituximab or basiliximab) or of a TNF-alpha blocker within the last 4 weeks prior to study entry
- •4 Simultaneous participation in another clinical trial
- •5 Body weight < 40 kg
- •6 Pregnant or lactating women
- •7 People who are not in a position to understand nature, significance and implications of the clinical study and to identify and align their will hereafter (pursuant to § 40 para 4 and § 41 para 2 and para 3 AMG)
- •8 Presence of CMV infection, HIV infection, replicative hepatitis B or hepatitis C, other serious infections, or a high risk for TB
- •9 Patients with previously known neutropenia (< 1.5/nl)
- •10 Heart failure NYHA stage III-IV
- •11 High-grade arrhythmias (eg ventricular tachycardia, symptomatic bradycardia , other hemodynamically significant arrhythmias )
- •12 Unstable coronary artery disease
- •13 History of splenectomy
- •14 Contraindication regarding a re-biopsy of the allograft (eg, coagulopathy, anticoagulation)
- •15 Presence of malignoma
- •16 Seronegativity (IgG) for EBV and VZV
- •17 Other exclusion criteria after assessment of the treating physician (eg, deterioration of general condition, derailed metabolic situation, high risk, such as AB0-incompatible kidney transplantation)
研究者
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