A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant (START-DCD)
A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
Primary Objective:
To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant.
Secondary Objectives:
- To evaluate delayed graft function (DGF), graft and patient survival after kidney transplant.
- To evaluate adverse events of Thymoglobuline® throughout the study.
- To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.
- To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant.
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
China、中国
- China
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria :
- Male or female.
- Patient is a Chinese recipient of kidney transplant for the first time.
- Patient is a recipient of kidney allograft from Chinese donors donated after cardiac death (including kidney donated after brain death followed by circulatory death).
- Recipient's age is between 18 to 65 years old (including 18 years).
- Donor's age is more than 5 years old.
- Recipient's weight is greater than or equal to 50 kg but less than or equal to 80 kg.
- Patient fully understands the study and signs the informed consent form (ICF) prior to any study procedure.
Exclusion criteria:
- Patient is a multiple organ transplant recipient.
- Recipient with previous kidney or other organ transplant history.
- Recipient and donor have incompatible blood types.
- Recipient and donor have 5 or 6 mismatched human leucocyte antigen (HLA).
- Recipient is known to have an active infection or active chronic infection, or is seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV Ab), or human immunodeficiency virus (HIV). (Serological test results within 12 months before transplantation are acceptable.)
- Recipient with cytomegalovirus (CMV) immunoglobulin G (IgG) negative who receives an allograft from CMV IgG positive donor (CMV IgG [D+/R-]).
- Any systemic infection requiring continuous treatment at enrolment, but prophylactic treatment of CMV and/or Pneumocystis carinii pneumonia (PCP) is allowed.
- Recipient has severe thrombocytopenia or leucopenia before operation (platelet count <75,000/ul, or the number of white blood cells <3,000 cells/mm3).
- Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamine transferase (GGT) ≥3ULN (upper limit of normal) within 1 week before transplantation, and not normalized at time of transplantation.
- Recipient has a history of malignancy within 5 years.
- Recipient with history of allergy and anaphylaxes to rabbit proteins or to any excipients.
- Recipient has known contraindications to the administration of Thymoglobuline®.
- Recipient has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 of half-lives from screening, whichever is longer.
- Recipient has previously used Thymoglobuline®, or has participated in any clinical trial of any other medicine or device within 30 days before signing ICF.
- Pregnant or lactating women.
- Male and female patients do not agree to practice medically acceptable contraception (i.e., barrier or pharmacologic: male patient must use condoms or his female partner must take oral contraceptives; the male partner of a female patient must use condoms ) for at least 6 months following the study treatment.
Conditions/situations such as:
- Recipient not suitable for participation, whatever the reason, as judged by the Investigator, including medical, clinical, or psychosocial conditions, or patient potentially at risk of noncompliance to study procedures.
- Donor known or suspected to have active infection before donation (such as blood cultures positive, seropositive for hepatitis B surface antigen [HBsAg], or antibody against hepatitis C virus [HCVAb], or human immunodeficiency virus [HIV]) or hypersensitive recipients (eg, panel reactive antibody [PRA] positive) before transplantation, judged by the Investigator.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Thymoglobuline
A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice. Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies. |
Pharmaceutical form: creamy-white powder Route of administration: intravenous
其他名称:
Pharmaceutical form: tablet Route of administration: oral Pharmaceutical form: powder Route of administration: intravenous Pharmaceutical form: capsule Route of administration: oral Pharmaceutical form: capsule Route of administration: oral Pharmaceutical form: tablet Route of administration: oral |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Percentage of patients with biopsy-proven acute rejection events
大体时间:6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Percentage of delayed graft function events
大体时间:6 months
|
6 months
|
Duration of delayed graft function events
大体时间:6 months
|
6 months
|
Percentage of survived grafts
大体时间:6 months
|
6 months
|
Percentage of survived patients
大体时间:6 months
|
6 months
|
Assessment of acute rejection risk factors
大体时间:6 months
|
6 months
|
Assessment of delayed graft function risk factors
大体时间:6 months
|
6 months
|
Percentage of acute rejection events in different risk stratifications
大体时间:6 months
|
6 months
|
Percentage of delayed graft function events in different risk stratifications
大体时间:6 months
|
6 months
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- THYMOL07282
- U1111-1178-5402 (其他标识符:UTN)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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