Use of Extracorporeal Photopheresis in Kidney Transplanta... | NCT07663669

Studies
Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection

NCT07663669

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Recruiting

Last Update Posted

Jun 29, 2026Actual

Enrollment

31Estimated

Phase

Not provided

Conditions

Antibody-mediated Rejection in Kidney Transplant

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Jun 17, 2026

First Submission Date that Met QC Criteria

Jun 17, 2026

First Posted Date

Jun 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2026

Last Update Posted Date

Jun 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	One year after initiation of ECP

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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"

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Kidney transplant recipients presenting with antibody-mediated rejection and treated with extracorporeal photopheresis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charline Vauchy, PhD.	Contact	+33381218875		cvauchy@chu-besancon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Besançon	Recruiting	Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided