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Renaparin® in Kidney Transplantation

Primary Purpose

Delayed Graft Function

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Renaparin
Placebo
Sponsored by
Corline Biomedical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delayed Graft Function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Transplantationscentrum, Sahlgrenska University Hospital
  • Department of Transplantation Surgery, Karolinska University Hospital, Huddinge
  • Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Renaparin

Placebo

Arm Description

Solution administered once to kidney ex-vivo

Placebo administered once to kidney ex-vivo

Outcomes

Primary Outcome Measures

Adverse Events
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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2018
Last Updated
June 30, 2020
Sponsor
Corline Biomedical AB
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1. Study Identification

Unique Protocol Identification Number
NCT03773211
Brief Title
Renaparin® in Kidney Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corline Biomedical AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Graft Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renaparin
Arm Type
Experimental
Arm Description
Solution administered once to kidney ex-vivo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered once to kidney ex-vivo
Intervention Type
Drug
Intervention Name(s)
Renaparin
Intervention Description
50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
Primary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Sedigh, MD
Organizational Affiliation
Section of Transplantation Surgery, Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transplantationscentrum, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Department of Transplantation Surgery, Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Renaparin® in Kidney Transplantation

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