2022-501389-23-02尚未招募2 期
A 3-month, phase 2, single-blind, randomised, no-treatment controlled study assessing efficacy and safety of Renaparin® for improvement of kidney graft function in deceased-donor transplant recipients, with an additional 9-month follow-up.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- The primary endpoint is the estimated glomerular filtration rate (eGFR) at Month 3, calculated using the MDRD 4 equation.
研究概览
简要总结
To assess the effect of Renaparin on graft function in renal transplant patients at high risk of ischemia-reperfusion injury (IRI) and delayed graft function (DGF) who have received a kidney – preserved in SCS – from a deceased donor that meets the criteria for DBD-ECD or DCD.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Single (Subject, Monitor, Analyst)
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
- •Organs: A kidney must fulfil the following criteria in order to be used in the study: 1) Kidney must come from a deceased donor at least 18 years of age. 2) Kidneys donated after brain death (DBD-ECD) or kidneys donated after circulatory death (DCD).
- •Patients: A patient must fulfil the following criteria in order to be included in the study: 3) Male or female patient 18 – 75 years of age. 4) Dialysis-dependent (initiated more than two months prior to transplantation) patient, acceptable candidate for kidney transplantation. 5) Female patients must be post-menopausal, surgically sterile or using effective methods of contraception during study treatment (3 months)*. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include: a) Combined (oestrogen and progestogen containing hormonal contraception associated with inhibition of ovulation -oral -intravaginal -transdermal b) progestogen-only hormonal contraception associated with inhibition of ovulation -oral -injectable -implantable c) intrauterine device d) intrauterine hormone-releasing system e) bilateral tubal occlusion f) vasectomized partner 6) Patient weight 45-115 kg. 7) Negative crossmatch test prior to transplantation and no evidence of donor-specific antibodies. 8) Patients able to give informed consent to participate in study.*Note: As per the Clinical Trial Facilitation Group (CTFG), the definition of woman of childbearing potential is as follows: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.
排除标准
- •Organs: The presence of any of the following will exclude a kidney from being used in the study: 1) Kidney judged by the transplantation surgeon on call as not appropriate for transplantation. 2) Kidney allograft that was on HMP > 6 hrs prior to administration of IMP, or prior to transplantation for the control kidney. 3) Kidney judged to need preservation by HMP up until transplantation.
- •Patients: The presence of any of the following will exclude a patient from participating in the study: 4) Increased risk of thrombosis (e.g., homozygous activated protein C [APC]-resistance) or bleeding (INR>1.5). 5) History of heparin-induced thrombocytopenia (HIT). 6) Known fish allergy. 7) History of or positive for human immunodeficiency virus (HIV). 8) Acute infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). 9) History of oncological malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. 10) Previous kidney transplantation. 11) Scheduled to undergo multi-organ transplantation or dual kidney transplantation. 12) Positive T or B cell crossmatch by NIH anti-globulin lymphocytotoxicity method or positive T or B cell flow cytometry crossmatch AND donor specific anti-HLA antibody (DSA) detected by flow cytometry/Luminex based, antigen specific anti-HLA antibody testing, according to local practise. 13) Current drug and/or alcohol abuse. 14) 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. 15) Lactating or pregnant women or women who intend to become pregnant. 16) Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree of heart block or cardiac arrhythmia associated with haemodynamic stability. 17) Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion. 18) Enrolment in another concurrent clinical interventional study, or intake of an IMP, within 3 months prior to inclusion in this study. 19) Foreseeable inability to cooperate with given instructions or study procedures. 20) Patients receiving prophylactic treatment of lymphocyte-depleting agents (e.g., anti-thymocyte globulin [ATG] or Campath). 21) Hypersensitivity to the IMP or to any of the excipients, or previous hypersensitivity to heparin as well as any contraindication for heparin.* *Note: Contraindication includes (but not limited to – depending on the investigator’s decision): - Current or history of allergic thrombocytopenia to heparin (heparin-associated thrombocytopenia type II) - Active major bleeding and risk factors for major bleeding - Septic endocarditis - Spinal anesthesia, epidural anesthesia, lumbar puncture - Diseases where there is a suspicion of a lesion of the vascular system, e.g. Gastric and/or intestinal ulcers, consistent hypertension (greater than 110 mmHg diastolic), cerebral hemorrhage, trauma or central nervous system surgery, eye surgery, retinopathy, vitreous hemorrhage, cerebral artery aneurysm.
结局指标
主要结局
The primary endpoint is the estimated glomerular filtration rate (eGFR) at Month 3, calculated using the MDRD 4 equation.
The primary endpoint is the estimated glomerular filtration rate (eGFR) at Month 3, calculated using the MDRD 4 equation.
次要结局
- Incidence of DGF (need for dialysis during first 7 days post-transplantation).
- Serum creatinine on Days 1-7, Day 30, and Months 3, 6, and 12.
- eGFR on Days 1-7, Day 30, Month 6 and Month 12.
- Severity of DGF, i.e., total number of dialysis sessions received by a patient through Day 30 in patients requiring dialysis within first 7 days post-transplantation.
- Incidence of functional DGF (fDGF), i.e., failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days during the first 7 days post-transplantation, irrespective of dialysis requirements, but discounting creatinine decrements because of dialysis itself.
- DGF duration (days); calculated from the date of kidney transplantation until the date of last dialysis session in patients who required at least one dialysis session within the first 7 days post-transplantation.
- The proportion of patients with immediate graft function (IGF), i.e., patients with creatinine reduction ratio (CRR) ≥30% between Day 1 and Day 2 post-transplant, irrespective of whether or not they had a single dialysis session within the first 7 days post-transplant.
- Proportion of patients with primary non-function (PNF), i.e., those who receive an allograft that never functions.
- The time to first dialysis (days) excluding patients with PNF.
- Urine output on Days 1-3.
研究者
Patrizia Caldirola
Scientific
Corline Biomedical AB
研究点 (8)
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