Antibody-mediated Rejection in Kidney TransplantPETRUMNCT07663669
Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection
An observational study of Antibody-mediated Rejection in Kidney Transplant, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal photopheresis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibody-mediated Rejection in Kidney Transplant
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Oct 2026
- Phase
- Observational
- 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
Study population: Kidney transplant recipients presenting with antibody-mediated rejection and treated with extracorporeal photopheresis
Who may be able to join
- Kidney transplant recipients followed at the University Hospitals of Besançon and Lille between September 1, 2016, and August 31, 2023
- Patients with antibody-mediated rejection (as confirmed by histological analysis of the renal biopsy)
- Rejection treated with extracorporeal photopheresis
- Subjects who do not object to the use of their personal data and/or biological samples
- Subjects affiliated with, or beneficiaries of, the French social security system
Who cannot join
- Patients with acute rejection
- Pregnant women, women in labor, or breastfeeding mothers
- Individuals deprived of liberty by judicial or administrative decision; individuals receiving compulsory psychiatric care; or individuals admitted to a healthcare or social institution for reasons other than research participation
- Minors
- Adults under legal protection or unable to provide informed consent
- Subjects without health insurance coverage
- Subjects currently within an exclusion period from another study, or as listed in the "national volunteer registry"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25000
Charline Vauchy, PhD., +33381218875, cvauchy@chu-besancon.fr
About this study
This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal photopheresis.
- Keywords
- Extracorporeal photopheresis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
Response is defined as either:
- stable serum creatinine at 1 year after initiation of ECP, corresponding to a variation within ±20% of baseline serum creatinine (responder); or
- a reduction in the slope of creatinine clearance decline following initiation of ECP compared with the pre-treatment trajectory (partial responder).
Participants meeting either criterion are considered responders for the primary efficacy analysis.
Measured: One year after initiation of ECP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-mediated Rejection in Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663669
- Sponsor's protocol ID
- 2026/1082
- Acronym
- PETRUM
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- 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
- Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection
- ClinicalTrials.gov ID
- NCT07663669
- Acronym / sponsor ID
- PETRUM / 2026/1082
- Keywords
- Extracorporeal photopheresis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jun 2026 (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.
This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal photopheresis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients presenting with antibody-mediated rejection and treated with extracorporeal photopheresis
Key inclusion criteria (5 listed)
- Kidney transplant recipients followed at the University Hospitals of Besançon and Lille between September 1, 2016, and August 31, 2023
- Patients with antibody-mediated rejection (as confirmed by histological analysis of the renal biopsy)
- Rejection treated with extracorporeal photopheresis
- Subjects who do not object to the use of their personal data and/or biological samples
- Subjects affiliated with, or beneficiaries of, the French social security system
Key exclusion criteria (7 listed)
- Patients with acute rejection
- Pregnant women, women in labor, or breastfeeding mothers
- Individuals deprived of liberty by judicial or administrative decision; individuals receiving compulsory psychiatric care; or individuals admitted to a healthcare or social institution for reasons other than research participation
- Minors
- Adults under legal protection or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year
Time frame: One year after initiation of ECP
Response is defined as either: * stable serum creatinine at 1 year after initiation of ECP, corresponding to a variation within ±20% of baseline serum creatinine (responder); or * a reduction in the slope of creatinine clearance decline following initiation of ECP compared with the pre-treatment trajectory (partial responder). Participants meeting either criterion are considered responders for the primary efficacy analysis.
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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody-mediated Rejection in Kidney Transplant, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 7 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 1 site 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 Charline Vauchy, PhD. (+33381218875, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with response to extracorporeal photopheresis (ECP) at 1 year (time frame: One year after initiation of ECP). 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.