Kidney TransplantationRECITENCT05890430
Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation
An observational study of Kidney Transplantation and Kidney Allograft Biopsy, run by University Hospital, Strasbourg, France.
Trial summary
We will study a prospective cohort including all kidney transplant recipients undergoing kidney graft biopsy in one kidney transplantation center, for a duration of 5 years. Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Kidney Allograft Biopsy, Humoral Rejection
- What is being tested?
- Blood draw, Urine draw
- How many people
- 570 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jul 2033
- 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: All kidney transplant recipients undergoing a kidney allograft biopsy for a duration of five years in a single kidney transplantation center.
Who may be able to join
- Kidney transplant recipient, male or female, 18 years of age or older
- Patient undergoing a kidney allograft biopsy, according to the usual protocol of the service
- Subject affiliated with a social health insurance scheme.
- Subject capable of understanding the objectives and risks associated with the research and expressing non-opposition
Who cannot join
- Inability to provide the subject with clear and proper information (difficulties in understanding the subject, ...)
- Refusal of the patient to participate in the study
- Subject under guardianship or curatorship
- Subjects under legal protection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation "REjet Cellules Immunitaires Transplantation rEnale" (RECITE)
We will study a prospective cohort including all kidney transplant recipients undergoing kidney graft biopsy in one kidney transplantation center, for a duration of 5 years.
Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection.
Our secondary outcomes are to describe the cellular, genetic, humoral, and histological characteristics of humoral rejection and their evolution.
Read the detailed description
Information and inclusion visit (V0) The information and inclusion visit will be carried out on the day of the graft biopsy or, in the case of pre-scheduled biopsies, during a consultation prior to the biopsy (still as part of standard follow-up). This is particularly the case for patients undergoing systematic biopsy. The indication for graft puncture-biopsy is generally decided by the nephrologist in charge of the patient, or at departmental meetings for complex cases.
During this consultation, the physician verifies the inclusion criteria and obtains the patient's consent to take part in the study. We explain to the patient the scientific interest of evaluating the immune response in humoral rejection, and the absence of repercussions for the patient's subsequent management. A routine clinical examination is performed, and the patient's current treatment regimen is notified.
If the patient agrees, a blood sample is taken for the standard biology follow-up of transplant patients and for the study samples:
- Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum
- PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity
- Urine: 5 dry tubes or SST 5 ml maximum
Patients will be divided into two groups according to the indication for biopsy, with an influence on follow-up:
- patients who underwent systematic biopsy (M3 and M12)
- patients included in a biopsy for cause, whatever the distance to the graft
Follow-up visits (V1, V2, V3, etc.) Subsequently, new samples may be offered to included patients, in order to compare the parameters studied at the time of and after their graft biopsies. The different follow-up times are indexed to the standard follow-up of kidney transplant patients.
-Patients routinely biopsied between M0 and M6 of transplantation (most often M3): Follow-up will be indexed to post-transplant consultation follow-up. New samples may be taken at M6, M9, M12 (at the time of the second systematic biopsy), M18, M24 of transplantation or during a follow-up biopsy.
Patients biopsied for cause, at any time post-transplant: follow-up will be indexed to the completion of patient follow-up consultations. New samples may be taken at M3, M6, M9, M12, M18, M24 after the biopsy, or during a follow-up biopsy.
With the patient's consent, blood and urine samples are taken for the standard follow-up biology of transplant patients and for the study samples:
- Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum
- PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity
- Urines: 5 dry tubes or SST 5 ml
- Conditions
- Kidney Transplantation, Kidney Allograft Biopsy, Humoral Rejection, Microvascular Inflammation
- Being tested
- Blood draw, Urine draw
- Keywords
- Kidney Transplantation, Humoral rejection, Kidney allograft biopsy, Alloimmunization, Genetic incompatibilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw, Urine drawBiological
Collection of an additional volume of blood at each follow-up time in addition to the standard blood test performed during the patient's follow-up Collection of an additional volume of urine at each follow-up time
| Study group | Role | What they receive |
|---|---|---|
| Patients with microvascular inflammation | Patients presenting with microvascular inflammation on kidney allograft biopsy Receives: Biological: Blood draw, Urine draw | |
| Patient without microvascular inflammation | Patients presenting without microvascular inflammation on kidney allograft biopsy Receives: Biological: Blood draw, Urine draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating CD3- CD56+ cells
Comparison between patients with microvascular inflammation and other patients
Measured: Day of inclusion sample (= day of kidney allograft biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2033 (estimated)
- Study completionJul 2033 (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, Strasbourg, FranceThe 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
- Prospective
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890430
- Sponsor's protocol ID
- 8968
- Acronym
- RECITE
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation "REjet Cellules Immunitaires Transplantation rEnale" (RECITE)
- ClinicalTrials.gov ID
- NCT05890430
- Acronym / sponsor ID
- RECITE / 8968
- Conditions
- Kidney Transplantation, Kidney Allograft Biopsy, Humoral Rejection, Microvascular Inflammation
- Keywords
- Kidney Transplantation, Humoral rejection, Kidney allograft biopsy, Alloimmunization, Genetic incompatibilities
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 6 Jun 2023 (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.
We will study a prospective cohort including all kidney transplant recipients undergoing kidney graft biopsy in one kidney transplantation center, for a duration of 5 years.
Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection.
Our secondary outcomes are to describe the cellular, genetic, humoral, and histological characteristics of humoral rejection and their evolution.
Detailed description
Information and inclusion visit (V0) The information and inclusion visit will be carried out on the day of the graft biopsy or, in the case of pre-scheduled biopsies, during a consultation prior to the biopsy (still as part of standard follow-up). This is particularly the case for patients undergoing systematic biopsy. The indication for graft puncture-biopsy is generally decided by the nephrologist in charge of the patient, or at departmental meetings for complex cases.
During this consultation, the physician verifies the inclusion criteria and obtains the patient's consent to take part in the study. We explain to the patient the scientific interest of evaluating the immune response in humoral rejection, and the absence of repercussions for the patient's subsequent management. A routine clinical examination is performed, and the patient's current treatment regimen is notified.
If the patient agrees, a blood sample is taken for the standard biology follow-up of transplant patients and for the study samples:
- Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum
- PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity
- Urine: 5 dry tubes or SST 5 ml maximum
Patients will be divided into two groups according to the indication for biopsy, with an influence on follow-up:
- patients who underwent systematic biopsy (M3 and M12)
- patients included in a biopsy for cause, whatever the distance to the graft
Follow-up visits (V1, V2, V3, etc.) Subsequently, new samples may be offered to included patients, in order to compare the parameters studied at the time of and after their graft biopsies. The different follow-up times are indexed to the standard follow-up of kidney transplant patients.
-Patients routinely biopsied between M0 and M6 of transplantation (most often M3): Follow-up will be indexed to post-transplant consultation follow-up. New samples may be taken at M6, M9, M12 (at the time of the second systematic biopsy), M18, M24 of transplantation or during a follow-up biopsy.
Patients biopsied for cause, at any time post-transplant: follow-up will be indexed to the completion of patient follow-up consultations. New samples may be taken at M3, M6, M9, M12, M18, M24 after the biopsy, or during a follow-up biopsy.
With the patient's consent, blood and urine samples are taken for the standard follow-up biology of transplant patients and for the study samples:
- Serum factors: 4 dry tubes or SST or EDTA 5 ml maximum
- PBMCs: 8 heparinized tubes of 10 ml maximum, which may be replaced by Paxgen tubes in case of technical or logistical necessity
- Urines: 5 dry tubes or SST 5 ml
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with microvascular inflammation | – | Biological: Blood draw, Urine drawPatients presenting with microvascular inflammation on kidney allograft biopsy |
| Patient without microvascular inflammation | – | Biological: Blood draw, Urine drawPatients presenting without microvascular inflammation on kidney allograft biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All kidney transplant recipients undergoing a kidney allograft biopsy for a duration of five years in a single kidney transplantation center.
Key inclusion criteria (4 listed)
- Kidney transplant recipient, male or female, 18 years of age or older
- Patient undergoing a kidney allograft biopsy, according to the usual protocol of the service
- Subject affiliated with a social health insurance scheme.
- Subject capable of understanding the objectives and risks associated with the research and expressing non-opposition
Key exclusion criteria (4 listed)
- Inability to provide the subject with clear and proper information (difficulties in understanding the subject, ...)
- Refusal of the patient to participate in the study
- Subject under guardianship or curatorship
- Subjects under 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 |
|---|---|---|
| Blood draw, Urine drawCollection of an additional volume of blood at each follow-up time in addition to the standard blood test performed during the patient's follow-up Collection of an additional volume of urine at each follow-up time | Biological | Patient without microvascular inflammation, Patients with microvascular inflammation |
Primary outcome
Number of circulating CD3- CD56+ cells
Time frame: Day of inclusion sample (= day of kidney allograft biopsy)
Comparison between patients with microvascular inflammation and other patients
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 8 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Kidney Allograft Biopsy, run by University Hospital, Strasbourg, 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 CAILLARD-OHLMANN, PU-PH (03 69 55 05 11, sophie.caillard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating CD3- CD56+ cells (time frame: Day of inclusion sample (= day of kidney allograft biopsy)). 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 8 Jun 2023.