ACTRN12624000567527尚未招募2 期
A Phase II Trial to Evaluate the Safety and Efficacy of clazakizumab for the desensitisation of highly sensitized patients on the deceased donor kidney transplant waiting list
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1.Age 18-70 years at the time of screening.
- •2.Highly sensitized:
- •a.with a cPRA of greater than 98% based on their current unacceptable HLA antigens on the transplant waiting list.
- •b.Must remain highly sensitized with a cPRA greater than 95% after altering unacceptable HLA antigens to only include those to which they have current antibodies detected by Luminex screening with an MFI greater than 1500 or lower if it is an antibody against a repeat HLA mismatch from a previous transplant, if it appears likely that an anti-HLA antibody is binding multiple different Luminex beads leading to an apparent lowering of the MFI or if a previous surrogate flow cytometric crossmatch was positive due to that antibody.
- •3.Must have end-stage kidney disease and currently be active on the deceased donor kidney transplant waiting list for greater than 12 months.
- •4.Written informed consent obtained from subject (or legally acceptable representative).
排除标准
- •1.Participant is unable or unwilling to comply with study procedures in the opinion of the Investigator.
- •2.Requiring multi-organ transplant.
- •3.Pregnant, breastfeeding, or unwillingness to practice highly effective birth control during the study and for 5 months after last dose of study medication.
- •4.History of anaphylaxis.
- •5.Abnormal liver function test (LFTs) (alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/bilirubin greater than 1.5 times the upper limit of normal) at screening or other significant liver disease.
- •6.Latent or active tuberculosis:
- •a.Chest X-ray (CXR) in the past 6 months showing evidence of latent or active tuberculosis. If CXR is not available, it must be performed at screening.
- •b.Positive QuantiFERON-TB Gold test at screening.
- •7.Human Immunodeficiency Virus (HIV) positive at screening.
- •8.Presence of hepatitis B surface antigen (HBsAg) at screening
- •9.Hepatitis C virus (HCV) RNA positive at screening.
- •10.History of inflammatory bowel disease (except fully excised and recovered from the surgery for ulcerative colitis), clinically significant diverticular disease (unless fully excised and recovered from the surgery) or history of GI perforation.
- •11.Neutropenia (less than 1,000/mm3) or thrombocytopenia (less than 100,000/mm3) at screening.
- •12.Active infections requiring systemic (IV or oral) antimicrobial agents.
- •13.History or current opportunistic infection, including (but not limited to) the following: a nontuberculous mycobacterial infection, pneumocystis, aspergillosis, and toxoplasmosis.
- •14.Active viral infections such as CMV, EBV, JCV, and polyoma BK.
- •15.Current participation in an investigational drug trial.
- •16.Administration of a live vaccine within 6 weeks of screening, including but not limited to the following:
- •a. Adenovirus [Adenovirus vaccine live oral type 7]
- •b. Varicella [Varivax]
- •c. Hepatitis A [VAQTA]
- •d. Rotavirus [Rotashield]
- •e. Yellow fever [Y-F-Vax]
- •f. Measles and mumps live virus vaccine
- •g. Measles, mumps, and rubella vaccine [MMR-II]
- •h. Sabin oral polio vaccine
- •i. Rabies vaccines [IMOVAX Rabies I.D., RabAvert])
- •j. Present or previous (within 5 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin, non-recurrent (within 5 years) cervical carcinoma in-situ, DCIS following completion of therapy or T1a renal cell carcinoma.
- •17.Presence of a condition or abnormality (i.e., clinically significant endocrine, autoimmune, metabolic, neurological, psychiatric/psychological, renal, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment) that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjectsType 1 diabetes mellitusEUCTR2020-000444-58-DEAdocia80
进行中（未招募）
1 期
Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH, MabCampath) in Patients with Previously Treated B Cell Chronic Lymphocytic LeukemiaEUCTR2005-005074-69-GBGenzyme Europe BV85
进行中（未招募）
1 期
Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH, MabCampath) in Patients with Previously Treated B Cell Chronic Lymphocytic LeukemiaB-Cell Chronic Lymphocytic LeukemiaMedDRA version: 8.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaEUCTR2005-005074-69-BEGenzyme Europe BV85
进行中（未招募）
1 期
Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH, MabCampath) in Patients with Previously Treated B Cell Chronic Lymphocytic LeukemiaEUCTR2005-005074-69-CZGenzyme Europe BV85
招募中
1 期
A safety and efficacy study of treatment combinations with and without chemotherapy in adult patients with advanced upper gastrointestinal tract malignanciesEUCTR2021-006291-16-FRArcus Biosciences, Inc.360