BIOSUPORT: Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT03997253

Collaborator

(none)

300

Enrollment

Locations

Arm

46.4

Anticipated Duration (Months)

100

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 (UHF) "SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient.

UHF 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.

Condition or Disease	Intervention/Treatment	Phase
Organ Transplantation	Other: blood and urine samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

Actual Study Start Date :

Dec 21, 2020

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: blood and urine samples blood and urine samples at D0, D7, D14, M1, M3, M6 and M12	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.

Arm

Intervention/Treatment

Experimental: blood and urine samples

blood and urine samples at D0, D7, D14, M1, M3, M6 and M12

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.

Outcome Measures

Primary Outcome Measures

Survival of the graft [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 UHF SUPORT centers (Tours, Poitiers, Limoges)
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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Limoges hospital	Limoges	France
2	Poitiers Hospital	Poitiers	France	86000
3	Tours hospital	Tours	France	37000

Sponsors and Collaborators

University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT03997253

Other Study ID Numbers:

87RI18-0027

First Posted:

Jun 25, 2019

Last Update Posted:

Oct 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Limoges

organ transplantation, graft, biological collection.

Study Results

No Results Posted as of Oct 11, 2021