NCT06919003招募中2 期
Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (RTB-021)
National Institute of Allergy and Infectious Diseases (NIAID)4 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年9月22日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Difference between study arms in renal function
研究概览
简要总结
The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. The placebo looks exactly like Berinert but does not contain any active drug. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Neither you or the study doctor can choose or know which group is assigned.
The primary objective is to test whether intrarenal artery C1 esterase inhibitor (C1INH) injection into the donor kidney prior to transplantation improves kidney function in recipients of high risk, deceased donor kidney transplants as measured by 12-month Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This study is a double-blind, placebo-controlled study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be able to understand and provide informed consent
- •Adults who are on chronic dialysis therapy and are on the wait list for deceased donor kidney transplant
- •Recipients who are ABO compatible with donor allograft
- •Negative crossmatch and no donor specific anti-HLA antibody (DSA) on most recent pretransplant serum sample as determined by local site
- •Female participants of childbearing potential must have a negative pregnancy test upon study entry
- •All participants with reproductive potential must agree to use highly effective contraception for at least 12-moths post-transplant. Oral estrogen containing contraception must not be used during the first 3 months post-transplant
- •Hepatitis C Virus Ab positive participants with negative Hepatitis C virus (HCV) Polymerase chain reaction (PCR) are eligible if they have spontaneously cleared infection or are in sustained virologic remission
- •Hepatitis C Virus negative recipients of a Hepatitis C Virus positive organ are eligible if they will be treated with the intent of inducing a sustained virologic remission
- •Recipients of kidneys arriving to the transplant center on ex vivo hypothermic machine perfusion pumps are eligible
- •Vaccines up to date per Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials
- •Anticipated Cold Ischemia Time (CIT) >=12 hours
- •Kidney Donor Profile Index (KDPI) 21-95%. For KDPI 21-34% to be eligible, anticipated CIT must be >=24 hours
- •Patients with normal coagulation
排除标准
- •Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- •Any prior or concurrent non-renal solid organ, or cellular transplant, or waitlisted for multi-organ transplant
- •Patients receiving enbloc kidneys
- •Kidneys receiving normothermic perfusion
- •Patients with a known pro-thrombotic disorder
- •Patients with a history of thrombosis or hyper-coagulable state, excluding dialysis access clotting
- •Body mass index (BMI) >=40 kg/m^2
- •Patients with a history of Hereditary Angioedema or use of C1 esterase inhibitor (C1INH) containing products or recombinant C1INH within 15 days prior to study entry
- •Patients with a known hypersensitivity to treatment with Berinert
- •Patients requiring chronic anti-coagulation or anti-platelet therapy. ASA and NSAIDS are allowed
- •Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin
- •Patients who are positive for Hep B infection (Hepatitis B surface antigen (HBsAg)+ or anti-HBcore +)
- •Any active infection
- •Human immunodeficiency virus (HIV) infection
- •Enrollment in another investigational trial
- •Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
- •Current or planned use of immunomodulatory agents including but not limited to rituximab, belatacept, eculizumab, JAK inhibitors, anti-TNF agents
- •Female participants who are pregnant or lactating
- •Past or current medical problems, inclusive of mental health and substance abuse concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
研究组 & 干预措施
Berinert
Experimental
干预措施: Berinert (Biological)
Saline
Placebo Comparator
干预措施: Placebo for Berinert (Other)
结局指标
主要结局
Difference between study arms in renal function
时间窗: At 12-months post-transplantation
Measured as Estimated Glomerular Filtration Rate Chronic Kidney Disease Epidemiology Collaboration (eGFRCKD-EPI) in ml/min/1.73m\^2
次要结局
- Incidence of Graft loss (including primary non function)(At 12-months post-transplantation)
- Comparison between the treated and control group of the full iBox score(At 12-months post-transplantation)
- Incidence of biopsy proven acute rejection (BPAR)(At 12-months post-transplantation)
- Incidence of proteinuria(At 12-months post-transplantation)
- Incidence of de novo donor specific anti-Human Leukocyte Antigen (HLA) antibody (DSA)(At 12-months post-transplantation)
- Incidence of Grade 3 or higher infections(At 12-months post-transplantation)
- Incidence of Grade 3 or higher intraoperative or postoperative hemorrhage(Within 4 weeks after transplantation)
- Incidence of thrombotic or thromboembolic events(Within 4 weeks after transplantation)
- Incidence of T cell mediated rejection (TCMR) that is steroid resistant(At 12-months post-transplantation)
- Incidence of TCMR that is BANFF grade 2 or higher(At 12-months post-transplantation)
- Incidence of antibody mediated rejection (ABMR)(At 12-months post-transplantation)
- Incidence of death(At 12-months post-transplantation)
研究者
研究点 (4)
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