Renaparin® in Kidney Transplantation

• Status: Completed
• Trial end date: 2020-04-21
• Target enrollment: 0
• Participant gender: All

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 receive a kidney treated with Renaparin, while the other half of the patient group will receive a kidney treated with placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corline Biomedical AB

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/):

1. Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation

• oral

• intravaginal

• transdermal

2. progestogen-only hormonal contraception associated with inhibition of ovulation

• oral

• injectable

• implantable

3. intrauterine device

4. intrauterine hormone-releasing system

5. bilateral tubal occlusion

6. 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