Status:
COMPLETED
Renaparin® in Kidney Transplantation
Lead Sponsor:
Corline Biomedical AB
Conditions:
Delayed Graft Function
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 r...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03773211
Start Date
February 14 2019
End Date
April 21 2020
Last Update
July 1 2020
Active Locations (3)
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1
Transplantationscentrum, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
2
Department of Transplantation Surgery, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
3
Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital
Uppsala, Sweden, 75185