Renaparin® in Kidney Transplantation

Corline Biomedical

Status and phase: Completed; Phase 1

Conditions: Delayed Graft Function

Treatments: Drug: Renaparin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03773211

RENAPAIR 01

Details and patient eligibility

About

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.

Full 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 dialysis in the immediate time-period after transplantation. In the longer perspective DGF is associated with increased risk of graft failure, thus decreasing the efficacy of the kidney transplantation.

Renaparin is a new product under development for the prevention of DGF in association with kidney transplantation. The product binds to the kidney vascular endothelium and its pharmacological effect is based on a local and effective presentation of heparin. Renaparin is administered ex vivo to the kidney by adding it to the preservation solution during Hypothermic Machine Perfusion (HMP) prior to transplantation.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Renaparin

Experimental group

Description:

Solution administered once to kidney ex-vivo

Treatment:

Drug: Renaparin

Placebo

Placebo Comparator group

Description:

Placebo administered once to kidney ex-vivo

Treatment:

Drug: Placebo