2024-512444-29-00招募中3 期
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)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 362
- 试验地点
- 4
- 主要终点
- kidney: delayed graft function has been picked as the main endpoint liver: The success of liver transplantation is determined by the area under the curve of GPT (ALT) measurements over the first 7 days after implantation (AUC)
研究概览
简要总结
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 kidney-pancreas.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Donor criteria - For All patients undergoing deceased donation: - deceased adult (≥18 years) donors fulfilling the criteria for organ donation
- •donor criteria - For All patients undergoing living kidney donation: - adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
- •recipients awaiting their transplant
- •recipients ≥18 years
- •recipients' signed informed consent before the transplantation
- •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
- •According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.
- •Liver recipient - re-transplantation
- •general refusal of organ donation
- •donation after cardiac death (DCD)
- •pregnant or lactating patients
- •recipients participating in any interventional study (e.g. another study involv-ing compound/interventions aimed at the reduction of preservation and/or is-chemia/reperfusion injury)
- •all combined allocations other than pancreas and kidney
- •double kidney transplantation
- •pancreas re-transplantation
- •machine perfusion
结局指标
主要结局
kidney: delayed graft function has been picked as the main endpoint liver: The success of liver transplantation is determined by the area under the curve of GPT (ALT) measurements over the first 7 days after implantation (AUC)
kidney: delayed graft function has been picked as the main endpoint liver: The success of liver transplantation is determined by the area under the curve of GPT (ALT) measurements over the first 7 days after implantation (AUC)
次要结局
- kidney 4. Biopsy proven rejections
- 1. Absolute peak LDH within 7 days after transplantation
- liver 2. Moment (day) of peak GPT and peak LDH
- Kidney 1. Incidence of primary poor function (creatinine at 3 month: >250 mol/l)
- Kidney 2. Serum creatinine, creatinine MDRD clearance, urea, and hemoglobin after 3 months
- kidney 3. Requirement of dialysis until 3 month after transplantation
- liver 3. Serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months
- liver 4. Biliary complications: number of episodes of cholestasis, therapy for chol-angitis, episodes of biliary leakage and intrahepatic and/or extrahepatic bil-iary strictures
- Pancreas 1. Insulin requirements on days 3 and 30 and after 3 months
- pancreas 2. α-amylase, lipase, C-reactive protein (CRP) at 1 und 3 days
- pancreas 3. C-peptide and HBA1c at day 30 and 3 months
- pancreas 4. Pancreatic complications: graft pancreatitis, anastomotic leak, vascular complications (thrombosis, stenosis, bleeding)
- pancreas 5. Fasting glucose at 3 months
研究者
Roman Petrov
Scientific
Dr. Franz Koehler Chemie GmbH
研究点 (4)
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