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

Not Applicable

• Conditions: Kidney Preservation and Transportation
• Interventions: Device: TB1-K

• Registration Number: NCT03600285
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-29
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Primary Completion: 2019-02-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TB1-K	TB1-K	TB1-K preservation arm

Primary Outcome Measures

Name	Time	Method
Rate of DGF	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.

Trial Locations

Locations (3)

Hospital Unviersitario de Bellvitge; 🇪🇸 Barcelona, Hospitalet De Llobregat, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain