NCT03600285 (EMERGE) is a NA clinical trial of TB1-K in Kidney Preservation and Transportation, sponsored by Transplant Biomedicals, S.L..

Who is sponsoring NCT03600285?

NCT03600285 is sponsored by Transplant Biomedicals, S.L..

What drugs are being tested in NCT03600285?

Interventions in NCT03600285: TB1-K.

What condition does NCT03600285 study?

NCT03600285 studies Kidney Preservation and Transportation.

Is NCT03600285 still recruiting?

NCT03600285 is currently status unknown. Last updated 21 June 2019.

Last reviewed 2019-06-21 · How we verify

NCT03600285: EMERGE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown NA Last updated 21 June 2019

What this trial tests

NA trial testing TB1-K in Kidney Preservation and Transportation in 32 participants. Status unknown.

Timeline

29 June 2018

Primary endpoint
15 February 2019

31 March 2020

Quick facts

Lead sponsor	Transplant Biomedicals, S.L.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	32
Start date	29 June 2018
Primary completion	15 February 2019
Estimated completion	31 March 2020
Sites	3 locations across Spain

Drugs / interventions tested

TB1-K

Conditions studied

Kidney Preservation and Transportation — all drugs for Kidney Preservation and Transportation →

Sponsor

Transplant Biomedicals, S.L.

Who can join

18 and older, any sex, with Kidney Preservation and Transportation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03600285 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Transplant Biomedicals, S.L.
Last refreshed: 21 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03600285.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing