A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 362
- 试验地点
- 4
- 主要终点
- Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)
研究概览
简要总结
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)
Protocol number: CL-N-KLP-TX-III/07-AT/17
Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver.
Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days).
Purpose of the study
The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas.
Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study.
Planned number of patients (recipients)
In total N=362 including:
Kidney 242 (including approx. 30 combined kidney-pancreas)
Liver 120
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All organs (kidney, combined kidney - pancreas and liver) Donor criteria
- •For All patients undergoing deceased donation:
- •- deceased adult (≥18 years) donors fulfilling the criteria for organ donation
- •For All patients undergoing living kidney donation:
- •- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
- •Patient (recipient) criteria
- •recipients awaiting their transplant
- •recipients ≥18 years
- •recipients' signed informed consent before the transplantation Kidney / combined kidney - pancreas recipients
- •n/a Liver recipient
- •full organ transplantation
排除标准
- •All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)
- •- donors whose organs are all allocated out of retrieving study center
- •general refusal of organ donation
- •donation after cardiac death (DCD) Patient (recipient) criteria
- •pregnant or lactating patients
- •recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and / or ischemia / reperfusion injury)
- •all combined allocations other than pancreas and kidney
- •Kidney / combined kidney -pancreas recipient
- •double kidney transplantation
- •pancreas retransplantation
- •machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.
- •Liver recipient
- •retransplantation
- •machine perfusion
研究组 & 干预措施
Liver Custodiol-N
干预措施: Custodiol-N Solution (Drug)
Kidney Custodiol-N
干预措施: Custodiol-N Solution (Drug)
Kidney Custodiol
干预措施: Custodiol HTK Solution (Drug)
Liver Custodiol
干预措施: Custodiol HTK Solution (Drug)
Kidney/Pancreas Custodiol-N
干预措施: Custodiol-N Solution (Drug)
Kidney/Pancreas Custodiol
干预措施: Custodiol HTK Solution (Drug)
结局指标
主要结局
Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)
时间窗: 7 days
Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation
时间窗: 7 days
次要结局
未报告次要终点