Renaparin® in Kidney Transplantation
Delayed Graft Function
About this trial
This is an interventional prevention trial for Delayed Graft Function
Eligibility Criteria
Inclusion Criteria:
Organs:
- 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
Patients:
- 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
Exclusion Criteria:
Organs:
- 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.
Patients:
- 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
- oral
- intravaginal
- transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation
- oral
- 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
Sites / Locations
- Transplantationscentrum, Sahlgrenska University Hospital
- Department of Transplantation Surgery, Karolinska University Hospital, Huddinge
- Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Renaparin
Placebo
Solution administered once to kidney ex-vivo
Placebo administered once to kidney ex-vivo