NCT03773211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

December 10, 2018

Last Update Submit

June 30, 2020

Conditions

Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Study Arms (2)

Renaparin

EXPERIMENTAL

Solution administered once to kidney ex-vivo

Drug: Renaparin

Placebo

PLACEBO COMPARATOR

Placebo administered once to kidney ex-vivo

Drug: Placebo

Interventions

RenaparinDRUG

50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation

Renaparin
PlaceboDRUG

50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Transplantationscentrum, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Department of Transplantation Surgery, Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Location

Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amir Sedigh, MD

    Section of Transplantation Surgery, Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 12, 2018

Study Start

February 14, 2019

Primary Completion

April 21, 2020

Study Completion

April 21, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations

SE(3)