Kidney Preservation and TransportationEMERGENCT03600285
Prospective, Single-Arm, Study to Assess the Safety and Performance of the TB1-K Device for Organ Preservation in Donor Kidneys for Transplantation
A study testing TB1-K in people with Kidney Preservation and Transportation, run by Transplant Biomedicals, S.L. at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Preservation and Transportation
- What is being tested?
- TB1-K
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesSpain
- Study dates
- 29 Jun 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Donor Inclusion Criteria:
- Donor kidney suitable for preservation
- Only one kidney per donor will be included
- Cold ischemia time (CIT) ≤ 24 hours
- Donor age over 18 years old
- Donor meets one of the following:
- Donor after brain death (DBD), standard and extended criteria
- Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
- Signed written informed consent
Donor Exclusion Criteria:
- 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
- Donor after circulatory death (DCD), Maastricht classification I, II, IV, V (See Definitions, section 14)
- Living donors
- Previous usage of a perfusion machine (PM)
- Kidneys not considered suitable for preservations
- Positive serology (HIV, Hepatitis B surface antigen \& C)
Recipient Inclusion Criteria:
- Registered primary kidney transplant candidate, male or female
- Age ≥ 18 years old
- Signed written informed consent
Recipient Exclusion Criteria:
- Prior solid organ or bone marrow transplant
- Multi-organ transplant
- Active malignancy
- Active infection
- Pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method.
- Participation in another clinical trial.
- Patient with known donor-specific HLA antibody
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Unviersitario de Bellvitge
Barcelona, Hospitalet de Llobregat, 08907
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
About this study
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.
- Conditions
- Kidney Preservation and Transportation
- Being tested
- TB1-K
- Keywords
- VIVIAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB1-KDevice
Use of TB1-K for preservation and transport of donated kidneys
| Study group | Role | What they receive |
|---|---|---|
| TB1-K | Experimental | TB1-K preservation arm Receives: Device: TB1-K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of DGF
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.
Measured: 1 week after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start29 Jun 2018
- Primary completion15 Feb 2019
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Preservation and TransportationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transplant Biomedicals, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fritz Diekmann, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600285
- Sponsor's protocol ID
- TB/TB1K-001
- Acronym
- EMERGE
- Status last verified
- Jun 2019
- First submitted
- 6 Jul 2018
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03600285
- Acronym / sponsor ID
- EMERGE / TB/TB1K-001
- Conditions
- Kidney Preservation and Transportation
- Keywords
- VIVIAN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Transplant Biomedicals, S.L.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB1-K | Experimental | Device: TB1-KTB1-K preservation arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB1-KUse of TB1-K for preservation and transport of donated kidneys | Device | TB1-K |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fritz Diekmann, PhD principal investigator
Hospital Clinic of Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TB1-K in people with Kidney Preservation and Transportation, run by Transplant Biomedicals, S.L. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of DGF (time frame: 1 week after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.