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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03997253
Other study ID # 87RI18-0027
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2020
Est. completion date November 2025

Study information

Verified date March 2024
Source University Hospital, Limoges
Contact Sophie ALAIN, MD
Phone +33 5 55 056 728
Email sophie.alain@unilim.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications. The University Hospital Federation "FHU SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. FHU SUPORT 's ambition is based on a translational strategy that presents two priority areas: Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.


Recruitment information / eligibility

Status Recruiting
Enrollment 430
Est. completion date November 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female over 18 (no age limit) - affiliated to a social security organization - Recipient (s) of a kidney, liver or heart transplant - followed by at least one of the FHU SUPORT centers (Tours, Poitiers, Limoges, Rennes) - having given informed consent to participate in the cohort. Exclusion Criteria: - Patient unable to understand the information given by the investigator - People under the protection of justice

Study Design


Related Conditions & MeSH terms


Intervention

Other:
blood and urine samples
various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection

Locations

Country Name City State
France Limoges hospital Limoges
France Poitiers Hospital Poitiers
France Rennes Hospital Rennes
France Tours hospital Tours

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Limoges University Hospital Federation FHU SUPORT

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival of the graft 12 months
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