Organ TransplantationBIOSUPORTNCT03997253
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
A study testing blood and urine samples in people with Organ Transplantation, run by University Hospital, Limoges at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation
- What is being tested?
- blood and urine samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Dec 2020to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- Patient unable to understand the information given by the investigator
- People under the protection of justice
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Limoges hospital
Limoges
Sophie Alain, MD, +33 5 55 056 728, sophie.alain@unilim.fr
Véronique Loustaud-Ratti, MD
- Recruiting
Poitiers Hospital
Poitiers, 86000
Antoine Thierry, MD, a.thierry@chu-poitiers.fr
Antoine Thierry
- Not yet recruiting
Rennes Hospital
Rennes, 35000
Florian LEMAITRE, Florian.LEMAITRE@chu-rennes.fr
Erwan Flecher
- Recruiting
Tours hospital
Tours, 37000
Ephrem Salame, MD, ephrem.salame@univ-tours.fr
Ephrem Salame
About this study
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.
- Conditions
- Organ Transplantation
- Being tested
- blood and urine samples
- Keywords
- organ transplantation, graft, biological collection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urine samplesOther
various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection
| Study group | Role | What they receive |
|---|---|---|
| blood, bile and urine samples | Experimental | blood and urine samples at D0,D1, D3 D7, D14, M1, M3, M6 and M12 Receives: Other: blood and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the graft
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start21 Dec 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Model description
- various blood and urine samples will be collected from the recipient at D0, D1, D3, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection ancillary studies : stools at D0 D7 M1 and M3 will be collected for liver transplant patient
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Federation FHU SUPORT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997253
- Sponsor's protocol ID
- 87RI18-0027
- Acronym
- BIOSUPORT
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
- ClinicalTrials.gov ID
- NCT03997253
- Acronym / sponsor ID
- BIOSUPORT / 87RI18-0027
- Conditions
- Organ Transplantation
- Keywords
- organ transplantation, graft, biological collection.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- University Hospital Federation FHU SUPORT
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Jun 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- various blood and urine samples will be collected from the recipient at D0, D1, D3, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection ancillary studies : stools at D0 D7 M1 and M3 will be collected for liver transplant patient
| Arm | Type | Receives |
|---|---|---|
| blood, bile and urine samples | Experimental | Other: blood and urine samplesblood and urine samples at D0,D1, D3 D7, D14, M1, M3, M6 and M12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient unable to understand the information given by the investigator
- People under the protection of justice
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 |
|---|---|---|
| blood and urine samplesvarious blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection | Other | blood, bile and urine samples |
Primary outcome
Survival of the graft
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
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Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
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In-situ vs Ex-situ Liver Preservation
Liver Disease (Alcoholic or Not), Transplantation
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and urine samples in people with Organ Transplantation, run by University Hospital, Limoges at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie ALAIN, MD (+33 5 55 056 728, sophie.alain@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the graft (time frame: 12 months). 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 29 Jun 2026.