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

• ClinicalTrials.gov Identifier: NCT03600285
• Recruitment Status: Unknown
• First Posted: July 26, 2018
• Last Update Posted: June 21, 2019
• Sponsor: Transplant Biomedicals, S.L.
• Information provided by (Responsible Party): Transplant Biomedicals, S.L.

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: February 15, 2019
• Estimated Study Completion Date: March 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: TB1-K; TB1-K preservation arm	Device: TB1-K; Use of TB1-K for preservation and transport of donated kidneys

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Spain

Hospital Unviersitario de Bellvitge

Barcelona, Hospitalet De Llobregat, Spain, 08907

Hospital Universitario Vall d'Hebron

Barcelona, Spain, 08035

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain, 08036

Sponsors and Collaborators

Transplant Biomedicals, S.L.

Investigators

• Principal Investigator: Fritz Diekmann, PhD; Hospital Clinic i provincial de Barcelona

More Information

• Responsible Party: Transplant Biomedicals, S.L.
• ClinicalTrials.gov Identifier: NCT03600285
• Other Study ID Numbers: TB/TB1K-001
• First Posted: July 26, 2018
• Last Update Posted: June 21, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Transplant Biomedicals, S.L.:

VIVIAN