CTIS2023-507895-36-00进行中（未招募）1 期
A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(siplizumab) Compared to Anti-Thymocyte Globulin (rATG), as Induction Therapy in de novo Renal Transplant Recipients - TCD601B101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Itb-Med AB
- 入组人数
- 46
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Able to understand the study requirements and provide written informed consent before any study assessment is performed., Male or female patients = 18 to 70 years of age., Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor., Recipients of a kidney with a cold ischemia time (CIT) < 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.
排除标准
- •Transplant recipients seronegative for Epstein-Barr virus (EBV)., History of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix., Subjects with clinically significant laboratory abnormality that would preclude participation in the study. For example: >2.5 × upper limit of normal (ULN) values for: - Liver function chemistries (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP]) - Bilirubin - Coagulation studies (International Normalized Ratio [INR]/prothrombin time [PT], activated partial thromboplastin time [aPTT])., Subjects with any of the following: • Hemoglobin (Hgb) < 8 mg/dL • White blood cell (WBC) count = 2,000/mm3 • Platelet count = 75,000/mm3., Seropositive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg). Subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment., Recipient of a kidney from a donor who tests positive for HIV, HBsAg/hepatitis B core antigen (HBcAg) positive or HCV., History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., siplizumab, anti-thymocyte globulin [ATG], tacrolimus [TAC], mycophenolate mofetil [MMF], corticosteroifs [CS])., Any additional contraindication to the use of TAC or MMF according to the national labeling information of these products (refer to the local product label)., Evidence of tuberculosis (TB) infection (after anti-TB treatment, patients with history of latent TB may become eligible according to national guidelines)., Subjects with severe systemic infections, current or within the two weeks prior to randomization., Subjects with any other clinically significant medical condition, active infection or laboratory abnormality that would, in the judgment of the Investigator, interfere with the subject’s ability to participate in the study., Multi-organ transplant recipients., Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol., Use of other investigational products or enrollment in another investigational drug study within 30 days of screening or 5 half-lives of the medication, whichever is longer., Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test., Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 24 weeks after the study medications have been stopped. Highly effective contraception methods include: Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. Any of the following: Use of oral, injected, or implanted hormo
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