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Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation (EMERGE)

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ClinicalTrials.gov Identifier: NCT03600285
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Transplant Biomedicals, S.L.

Brief Summary:

TB1-K Device is an organ preservation and transportation system, using ultrasound technology with a cooling system to preserve the organ in optimal conditions during transport to the transplant recipient.

This is a prospective, single-arm, multi-center study comparing to a historical control for cold storage.

The study is conducted in accordance with the Standard ISO 14155 (Clinical investigation of medical devices for human subjects - Good clinical practice), and other legal requirements.

The study objective is to assess the safety and performance of the TB1-K device in donor kidneys intended for transplantation.


Condition or disease Intervention/treatment Phase
Kidney Preservation and Transportation Device: TB1-K Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : May 31, 2020

Intervention Details:
  • Device: TB1-K
    Use of TB1-K for preservation and transport of donated kidneys


Primary Outcome Measures :
  1. Rate of DGF [ Time Frame: 1 week after transplant ]
    Rate of delayed graft function (DGF), defined as need for dialysis in the first week after transplant, once hyperacute rejection, vascular and urinary tract complications are ruled out.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Donor Inclusion Criteria:

  1. Donor kidney suitable for preservation
  2. Only one kidney per donor will be included
  3. Cold ischemia time (CIT) ≤ 24 hours
  4. Donor age over 18 years old
  5. Donor meets one of the following:

    1. Donor after brain death (DBD), standard and extended criteria
    2. Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
  6. Signed written informed consent

Donor Exclusion Criteria:

  1. Kidney, which investigator is unwilling to use, or presence of moderate or severe traumatic kidney injury, or anatomical kidney vascular abnormalities, which would preclude the organ from being acceptable by the transplant surgeon
  2. Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14)
  3. Living donors
  4. Previous usage of a perfusion machine (PM)
  5. Kidneys not considered suitable for preservations
  6. Positive serology (HIV, Hepatitis B surface antigen & C)

Recipient Inclusion Criteria:

  1. Registered primary kidney transplant candidate, male or female
  2. Age ≥ 18 years old
  3. Signed written informed consent

Recipient Exclusion Criteria:

  1. Prior solid organ or bone marrow transplant
  2. Multi-organ transplant
  3. Active malignancy
  4. Active infection
  5. Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method.
  6. Participation in another clinical trial.
  7. Patient with known donor-specific HLA antibody

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): NCT03600285


Contacts
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Contact: Diana Villanueva, MSc +34 93 527 27 20 ext 103 dvillanueva@transplantbiomed.com

Locations
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Spain
Hospital Unviersitario de Bellvitge Recruiting
Barcelona, Hospitalet De Llobregat, Spain, 08907
Contact: Salvador Gil-Vernet, PhD    +34 93 260 76 98    sgilvernet@bellvitgehospital.cat   
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Daniel Seron, PhD    +34 93 274 62 19    dseron@vhebron.net   
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Fritz Diekmann, PhD    +34 93 227 54 44    fdiekman@clinic.cat   
Sponsors and Collaborators
Transplant Biomedicals, S.L.
Investigators
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Principal Investigator: Fritz Diekmann, PhD Hospital Clinic i provincial de Barcelona

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Responsible Party: Transplant Biomedicals, S.L.
ClinicalTrials.gov Identifier: NCT03600285     History of Changes
Other Study ID Numbers: TB/TB1K-001
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No