Kidney TransplantationIPECAMNCT04870437
Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.
A study testing Extracorporeal phototherapy in people with Kidney Transplantation, run by University Hospital, Angers at 4 sites in France.
Trial summary
Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Extracorporeal phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Apr 2022to 27 Oct 2026
- 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
- ECP treatment decision based on transplant team habits (care management)
- Age ≥ 18 years
- Affiliation to a French social security scheme
- Kidney transplant at least 6 months prior to inclusion
- cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:
- allograft glomerulopathy (cg>0, and maximum score cg2) or intimal fibrosis
Show all 11Show fewer
- C4d positive or ptc+g greater than or equal to 2
- Presence of Donor Specific Antibody (DSA)
- Interstitial Fibrosis and Tubular Atrophy (IFTA) less than or equal to 2
- Glomerular filtration rate > 30 mL/min/1.73 m2
- Signed informed consent to participate in the study
Who cannot join
- Active infection or infection with hepatitis B, C or HIV virus
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person receiving psychiatric care under duress
- Person subject to legal protection
- Person out of state to express consent
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
Chu Besancon
Besançon
DIDIER DUCLOUX, DR, +3381219220, dducloux@chu-besancon.fr
- Recruiting
CHU Clermont Ferrand
Clermont-Ferrand
ANNE ELISABETH HENG, DR, +33473751427, aheng@chu-clermontferrand.fr
- Recruiting
Chu Saint Etienne
Saint-Etienne
CHRISTOPHE MARIAT, DR, +33477828380, christophe.mariat@univ-st-etienne.fr
- Recruiting
CHU de STRASBOURG
Strasbourg
SOPHIE CAILLARD OHLMANN, DR, sophie.caillard@chru-strasbourg.fr
About this study
Official title: Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM
Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring.
Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft.
Read more
The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated.
The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.
- Conditions
- Kidney Transplantation
- Being tested
- Extracorporeal phototherapy
- Keywords
- Chronic AntiBody-Mediated Rejection, ExtraCorporeal Phototherapy, Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal phototherapyOther
The principle of ECP is to collect mononucleated cells from the blood by centrifugation. After purification, the mononucleated cells are incubated ex-vivo with a photo-activatable DNA intercalating agent (8-methoxypsoralen, UVADEX®), then re-injected to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal phototherapy | Experimental | Not described Receives: Other: Extracorporeal phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of TFH cells and their activation markers
Variation in the frequency of TFH cells and their activation markers under treatment.
Measured: From the 1st session of ECP to 1 year after the 1st session
Secondary outcomes (6)
Subsequent ECP response in patients with cABMR
Study of the 3-month TFH/TFR value of ECP treatment as a marker for subsequent ECP response in patients with cABMR
Measured: 3 months of treatment per ECP
Concentration of pro and anti-inflammatory cytokines
Study of the concentration of pro-inflammatory cytokines (IL-6, TNFα, IL-1β, IL-17, IFN-gamma, IL-21, IL-12, IL-17, CXCL13) and anti-inflammatory cytokines (IL10, TGF-b) over time in ECP
Measured: From the 1st session of ECP to 1 year after the 1st session
Concentration of circulating B-cell populations
Study of the concentration of circulating B-cell populations due to ECP
Measured: From the 1st session of ECP to 1 year after the 1st session
Measurement of genetic markers in TFH cells
Study of genetic markers in TFH cells in cell co-culture in vitro to describe their function
Measured: At 1 week of the 1st session of ECP and at 3 month after the 1st session
Comparison of clinical data of patients
Clinical measures (medical examinations) of patients
Measured: From the 1st session of ECP to 1 year after the 1st session
Comparison of biological data of patients
Biological measures (blood samples) of patients
Measured: From the 1st session of ECP to 1 year after the 1st session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start27 Apr 2022
- Primary completion27 Oct 2026 (estimated)
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Therakos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870437
- Sponsor's protocol ID
- 2021-A00580-41
- Acronym
- IPECAM
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM
- ClinicalTrials.gov ID
- NCT04870437
- Acronym / sponsor ID
- IPECAM / 2021-A00580-41
- Conditions
- Kidney Transplantation
- Keywords
- Chronic AntiBody-Mediated Rejection, ExtraCorporeal Phototherapy, Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Therakos
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Oct 2026 (estimated)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 3 May 2021 (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.
Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring.
Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft.
The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated.
The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal phototherapy | Experimental | Other: Extracorporeal phototherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECP treatment decision based on transplant team habits (care management)
- Age ≥ 18 years
- Affiliation to a French social security scheme
- Kidney transplant at least 6 months prior to inclusion
- cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:
Key exclusion criteria (6 listed)
- Active infection or infection with hepatitis B, C or HIV virus
- Pregnant, breastfeeding or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person receiving psychiatric care under duress
- Person subject to legal protection
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 |
|---|---|---|
| Extracorporeal phototherapyThe principle of ECP is to collect mononucleated cells from the blood by centrifugation. After purification, the mononucleated cells are incubated ex-vivo with a photo-activatable DNA intercalating agent (8-methoxypsoralen, UVADEX®), then re-injected to the patient. | Other | Extracorporeal phototherapy |
Primary outcome
Frequency of TFH cells and their activation markers
Time frame: From the 1st session of ECP to 1 year after the 1st session
Variation in the frequency of TFH cells and their activation markers under treatment.
6 secondary outcomes
Subsequent ECP response in patients with cABMR
Time frame: 3 months of treatment per ECP
Concentration of pro and anti-inflammatory cytokines
Time frame: From the 1st session of ECP to 1 year after the 1st session
Concentration of circulating B-cell populations
Time frame: From the 1st session of ECP to 1 year after the 1st session
Measurement of genetic markers in TFH cells
Time frame: At 1 week of the 1st session of ECP and at 3 month after the 1st session
Comparison of clinical data of patients
Time frame: From the 1st session of ECP to 1 year after the 1st session
Comparison of biological data of patients
Time frame: From the 1st session of ECP to 1 year after the 1st session
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 6 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal phototherapy in people with Kidney Transplantation, run by University Hospital, Angers 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 11 inclusion and 6 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 6 Mar 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 Jean-François AUGUSTO, Pr (+33 2 41 35 50 63, JFAugusto@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of TFH cells and their activation markers (time frame: From the 1st session of ECP to 1 year after the 1st session). 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 6 Mar 2026.