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| Name | Class |
|---|---|
| Therakos | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal phototherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal phototherapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of TFH cells and their activation markers | Variation in the frequency of TFH cells and their activation markers under treatment. | From the 1st session of ECP to 1 year after the 1st session |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months of treatment per ECP |
| Concentration of pro and anti-inflammatory cytokines |
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Inclusion Criteria:
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:
Glomerular filtration rate > 30 mL/min/1.73 m2
Signed informed consent to participate in the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François AUGUSTO, Pr | Contact | +33 2 41 35 50 63 | JFAugusto@chu-angers.fr | |
| Emma BLANCHET | Contact | +33 2 41 35 63 38 | EmBlanchet@chu-angers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Besancon | Recruiting | Besançon | France |
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.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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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
| 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 | 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 | 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 | 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 | From the 1st session of ECP to 1 year after the 1st session |
| CHU Clermont Ferrand | Recruiting | Clermont-Ferrand | France |
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| Chu Saint Etienne | Recruiting | Saint-Etienne | France |
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| CHU de STRASBOURG | Recruiting | Strasbourg | France |
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