Clinical Drug Experience Knowledgebase

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