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Renaparin® in Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773211
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Corline Biomedical AB

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

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Renaparin Drug: Placebo Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase I Double Blind Placebo Controlled Safety Study of ex Vivo Treatment of Kidneys From Deceased Donors With Renaparin®, Followed by Transplantation to Study Population
Actual Study Start Date : February 14, 2019
Actual Primary Completion Date : April 21, 2020
Actual Study Completion Date : April 21, 2020

Arm Intervention/treatment
Experimental: Renaparin
Solution administered once to kidney ex-vivo
Drug: Renaparin
50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation

Placebo Comparator: Placebo
Placebo administered once to kidney ex-vivo
Drug: Placebo
50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 days ]
    Number and severity grade of Serious Adverse Events and Adverse Events including description of their associated MedDRA terms during the first 30 days after transplantation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773211


Locations
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Sweden
Transplantationscentrum, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Department of Transplantation Surgery, Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Corline Biomedical AB
Investigators
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Principal Investigator: Amir Sedigh, MD Section of Transplantation Surgery, Uppsala University Hospital
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Responsible Party: Corline Biomedical AB
ClinicalTrials.gov Identifier: NCT03773211    
Other Study ID Numbers: RENAPAIR 01
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes