EUCTR2018-002882-20-GB进行中（未招募）1 期
A multicentre randomised controlled trial to assess the safety and efficacy of adding rituximab to standard of care in treating acute antibody-mediated rejection in kidney transplantation (Transplant Antibody-mediated Rejection: Guiding Effective Treatments-1 (TAR:GET-1)) - TAR:GET-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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. Willing and able to give written informed consent by patient aged 16 years and over; or by a parent or legal guardian for patients who are under 16 years old
- •2. Aged 5 years old or older, at the time of consent
- •3. A diagnosis of acute AMR as defined by:
- •a.The presence of =1 donor specific antibodies (DSA)
- •b.An adequate transplant biopsy (=7 glomeruli and =1 artery) with histological features consistent with active AMR with no evidence of chronicity as defined by the Banff histological classification of allograft pathology:
- •i. If C4d positive (2 or 3):
- •v score =1 and/or
- •g score =1 and/or
- •thrombotic microangiopathy and/or
- •ptc score =1
- •or if co-existent cellular rejection, a g score of =1
- •ii. If C4d negative (0 or 1):
- •microcirculation inflammatory score (g + ptc) =2
- •or if co-existing cellular rejection, a g score =1 and (g + ptc) =2
- •Chronic glomerulopathy (cg) score 0 or 1a
- •Tubulo-interstitial fibrosis <50% and glomerular obsolescence <50%
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Patients who have received an ABO incompatible transplant
- •2.Patients who have received rituximab as part of induction or post-transplant for any other indications (eg. recurrent focal and segmental glomerular sclerosis)
- •3.Patients who have received complete PEX treatment prior to the index biopsy on the suspicion of acute AMR in the absence of histology
- •4.Have active infection including bacterial, viral (including CMV and EBV), fungal or tuberculosis, which in the investigator’s opinion could affect the conduct of the study
- •5.Co-existing BK nephropathy
- •6.Patients with hepatitis B (patients with prior exposure to hepatitis B may be enrolled at the discretion of the PI)
- •7.Have active hepatitis C (patients may be included if a negative hepatitis C recombinant immunoblot assay is confirmed or have a negative hepatitis C virus RNA [qualitative] test)
- •8.Active malignancy
- •9.Patients with known allergy, intolerance or contraindication to treatments in the standard of care arm or rituximab as outlined in the Summaries of Product Characteristics (SmPCs)
- •10.Clinically significant comorbidity
- •11. Females must be either post-menopausal for at least 1 year, surgically sterile or, if of child-bearing potential, must not be pregnant or lactating. If sexually active, female participants must agree to use an acceptable method of birth control for 12 months post rituximab treatment. Female participants must also agree not to breastfeed for 12 months post rituximab treatment.
研究者
相似试验
尚未招募
1 期
A multicenter randomized controlled trial to assess the efficacy of cancer green therapy in treatment of stage IIIb/IV non-small cell lung cancerlung cancerITMCTR1900002748Dongfang Hospital Beijing University of Chinese Medicine
招募中
3 期
Clinical trial of colonoscopy using computer-aided detection systems in colorectal cancer screeningJPRN-jRCT1032230396Saito Yutaka1,400
进行中（未招募）
3 期
A randomised controlled multicentre trial of imiquimod versus radiotherapy for lentigo maligna (LM) when staged surgical excision with 5mm margins is not possible, is refused, or fails.entigo maligna (LM)Lentigo maligna (LM)Cancer - Non melanoma skin cancerACTRN12615000266561Melanoma and Skin Cancer (MASC) Trials126
进行中（未招募）
1 期
Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSHighly active relapsing remitting multiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2019-001549-42-GBSheffield Teaching Hospitals198
进行中（未招募）
不适用
The Operative Rib Fixation (ORiF) studyRib fracturesInjury, Occupational Diseases, PoisoningFracture of ribISRCTN10777575ottingham University Hospitals NHS Trust467