Phase I Double Blind Placebo Controlled Safety Study of ex Vivo Treatment of Kidneys From Deceased Donors With Renaparin®, Followed by Transplantation to Study Population
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Adverse Events
研究概览
简要总结
This study evaluates the safety and tolerability of Renaparin in adult patients receiving a deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the patient group will receive a kidney treated with Renaparin, while the other half of the patient group will receive a kidney treated with placebo.
详细描述
Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in patients being put on dialysis in the immediate time-period after transplantation. In the longer perspective DGF is associated with increased risk of graft failure, thus decreasing the efficacy of the kidney transplantation.
Renaparin is a new product under development for the prevention of DGF in association with kidney transplantation. The product binds to the kidney vascular endothelium and its pharmacological effect is based on a local and effective presentation of heparin. Renaparin is administered ex vivo to the kidney by adding it to the preservation solution during Hypothermic Machine Perfusion (HMP) prior to transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Kidney must come from a deceased donor above 18 years of age
- •The regular protocols for organ donation according to Swedish law can be followed
- •Male and female patients 18 - 75 years of age.
- •Ability to provide written informed consent.
- •Mentally stable and able to comply with the procedures of the study protocol
- •Patient has been listed for kidney transplantation from a deceased donor at the clinical sites included in this study.
- •Negative crossmatch test prior to transplantation and no existence of donor-specific antibodies
- •Receiving first or second renal transplantation
排除标准
- •Organs from donors deceased due to cardiac death.
- •Organs which have not been adequately perfused during HMP, as judged by the transplantation surgeon on call.
- •Use of an investigational drug or other investigational treatment, that could interfere with the outcome of the present trial, in the 30 days' period before Study Day 1
- •Increased risk of thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5)
- •Anticoagulant treatment with Warfarin for indication unrelated to the kidney transplantation
- •History of heparin-induced thrombocytopenia (HIT)
- •History of or positive for HIV, HBV, or HCV
- •History of oncological malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
- •Scheduled to undergo multi-organ transplantation or dual kidney transplantation
- •Current drug and/or alcohol abuse
- •Known fish allergy
- •History or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would place the patient at an unacceptable risk for study participation
- •Lactating or pregnant women or women who intend to become pregnant
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study treatment. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include (in "Recommendations related to contraception and pregnancy testing in clinical trials", supplied from www.hma.eu/):
- •Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation
- •intravaginal
- •transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation
- •injectable
- •implantable
- •intrauterine device
- •intrauterine hormone-releasing system
- •bilateral tubal occlusion
- •vasectomized partner
- •Patients who the investigator considers not eligible to give informed consent
- •Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree of heart block or cardiac arrhythmia associated with hemodynamic stability
- •Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo a kidney transplantation
研究组 & 干预措施
Placebo
Placebo administered once to kidney ex-vivo
干预措施: Placebo (Drug)
Renaparin
Solution administered once to kidney ex-vivo
干预措施: Renaparin (Drug)
结局指标
主要结局
Adverse Events
时间窗: 30 days
Number and severity grade of Serious Adverse Events and Adverse Events including description of their associated MedDRA terms during the first 30 days after transplantation.
次要结局
未报告次要终点