Kidney Transplant RejectionDELIGHTNCT05785936
Immune Response in Desensitized Patients
An observational study of Kidney Transplant Rejection, run by University Hospital, Grenoble.
Trial summary
Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics. Sensitization with anti-Human Leukocyte Antigen antibodies is a barrier to access to transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Desensitization
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 highly sensitized patients: 10 that received desensitization before kidney transplan tation and 5 that were not desensitized before kidney transplantation. 5 healthy donors
Who may be able to join
- Adult patients (age >18 years) with end-stage renal disease (on hemodialysis or peritoneal dialysis or stage V chronic kidney disease) who are candidates for pre-renal transplantation desensitization from living or deceased donors.
- For women of childbearing age: a plasma pregnancy test before inclusion is mandatory. Highly effective contraception for women of childbearing age is required throughout the study period:
- combined hormonal contraception (containing estrogen and progestin)
- contraception associated with ovulation inhibition :
- oral
- intravaginal
Show all 21Show fewer
- transdermal
- Progestin-only hormonal contraception associated with ovulation inhibition:
- oral
- injectable
- implantable
- intrauterine device (IUD) - intrauterine hormone delivery system (IUS)
- bilateral tubal occlusion
- vasectomized partner
- sexual abstinence
- Have signed the DELIGHT protocol consent.
- Affiliated to a social security system
- Can be contacted in case of emergency
- For the control groups :
- Healthy controls from blood samples (centrifugation ring) from the French Blood Agency. The use of healthy controls is necessary to compare immunological analyses to a reference group without immunosuppression.
- Highly sensitized kidney transplant patients without the need for de-immunization. Hyperimmunization is defined by a Panel Reactive Antibody score > 85%. Transplantation can be from deceased or living donors.
Who cannot join
- Patients who object to the use of their data and/or samples in the research
- Patients having received an immunosuppressive treatment in the 12 months preceding the inclusion
- All protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection.
- Subjects in a period of exclusion from another study
- Subject under administrative or judicial supervision
- Subject unable to be contacted in case of emergency
About this study
Official title: Impact of Desensitization Therapies on the Immune Response of Highly Sensitized Patients Awaiting Kidney Transplantation
Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics. Sensitization with anti-Human Leukocyte Antigen antibodies is a barrier to access to transplantation.
Highly-sensitized patients wait 2 to 3 times longer on the waiting list with important health and economic consequences. Desensitization strategies by apheresis techniques allow access to a transplant with a negative crossmatch (absence of specific HLA antibodies against their donor) on the day of the transplant.
Read more
The main objective of this study is to assess the impact of desensitization on the antibody memory immune response in highly sensitized patients awaiting kidney transplantation.
The analyses will be based on samples from the 20 patients (10 desensitized transplanted patients, 5 highly sensitized non-desensitized transplanted patients and 5 healthy donors) at the University Hospital of Grenoble, France.
Analyses will include phenotypic and immuno-metabolic analysis by flow cytometry of antibody-secreting cells, a functional analysis by anti HLA ELISpot B technique and histological analysis of post-kidney transplantation follow-up renal biopsies with gene expression mapping (RNA tissue labeling using the Nanostring technique) within the renal parenchyma.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Desensitization
- Keywords
- HLA sensitization, Desensitization, Antibody secreting cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesensitizationProcedure or surgery
Patients that received apheresis and anti-cluster of differentiation antigen 20 for desensitization priori to kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Highly sensitized and desensitized kidney transplanted group | Patient that were HLA desensitized for kidney transplantation Receives: Procedure: Desensitization | |
| Highly sensitized and non-desensitized kidney transplanted group | Patient that were not HLA desensitized for kidney transplantation but were highly sensitized and received a kidney graft due to local priority system | |
| Healthy donors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow Cytometry analyses of Peripheral Blood Mononuclear Cells
Change of the percentage of "antibody secreting cells" (plasmablasts) over time
Measured: Before desensitization, at the time of transplantation and Before desensitization, at the time of transplantation and post transplantation
Change in Anti HLA B-cell ELISpot response
Change in the number of Spot over time
Measured: Before desensitization, at the time of transplantation and Month 3, Month 6 and Month 12 post transplantation
Change in Flow Cytometry analyses of medullary cells
Change in the percentage of "antibody secreting cells" (plasmablasts) over time
Measured: The first day of desensitization and at the day of kidney transplantation
Change in analyses of RNA expression on renal histology
CHange in percentage of gene expression using Nanostring technology
Measured: Month1, Month 3 and Month 12 post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noble_Johan, MD, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785936
- Sponsor's protocol ID
- 2022-A02445-38
- Acronym
- DELIGHT
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Desensitization Therapies on the Immune Response of Highly Sensitized Patients Awaiting Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05785936
- Acronym / sponsor ID
- DELIGHT / 2022-A02445-38
- Conditions
- Kidney Transplant Rejection
- Keywords
- HLA sensitization, Desensitization, Antibody secreting cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 27 Mar 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.
Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics. Sensitization with anti-Human Leukocyte Antigen antibodies is a barrier to access to transplantation.
Highly-sensitized patients wait 2 to 3 times longer on the waiting list with important health and economic consequences. Desensitization strategies by apheresis techniques allow access to a transplant with a negative crossmatch (absence of specific HLA antibodies against their donor) on the day of the transplant.
The main objective of this study is to assess the impact of desensitization on the antibody memory immune response in highly sensitized patients awaiting kidney transplantation.
The analyses will be based on samples from the 20 patients (10 desensitized transplanted patients, 5 highly sensitized non-desensitized transplanted patients and 5 healthy donors) at the University Hospital of Grenoble, France.
Analyses will include phenotypic and immuno-metabolic analysis by flow cytometry of antibody-secreting cells, a functional analysis by anti HLA ELISpot B technique and histological analysis of post-kidney transplantation follow-up renal biopsies with gene expression mapping (RNA tissue labeling using the Nanostring technique) within the renal parenchyma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Highly sensitized and desensitized kidney transplanted group | – | Procedure: DesensitizationPatient that were HLA desensitized for kidney transplantation |
| Highly sensitized and non-desensitized kidney transplanted group | – | –Patient that were not HLA desensitized for kidney transplantation but were highly sensitized and received a kidney graft due to local priority system |
| Healthy donors | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 highly sensitized patients: 10 that received desensitization before kidney transplan tation and 5 that were not desensitized before kidney transplantation. 5 healthy donors
Key inclusion criteria (21 listed)
- Adult patients (age >18 years) with end-stage renal disease (on hemodialysis or peritoneal dialysis or stage V chronic kidney disease) who are candidates for pre-renal transplantation desensitization from living or deceased donors.
- For women of childbearing age: a plasma pregnancy test before inclusion is mandatory. Highly effective contraception for women of childbearing age is required throughout the study period:
- combined hormonal contraception (containing estrogen and progestin)
- contraception associated with ovulation inhibition :
- Progestin-only hormonal contraception associated with ovulation inhibition:
Key exclusion criteria (6 listed)
- Patients who object to the use of their data and/or samples in the research
- Patients having received an immunosuppressive treatment in the 12 months preceding the inclusion
- All protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection.
- Subjects in a period of exclusion from another study
- Subject under administrative or judicial supervision
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 |
|---|---|---|
| DesensitizationPatients that received apheresis and anti-cluster of differentiation antigen 20 for desensitization priori to kidney transplantation | Procedure or surgery | Highly sensitized and desensitized kidney transplanted group |
Primary outcome
Change in Flow Cytometry analyses of Peripheral Blood Mononuclear Cells
Time frame: Before desensitization, at the time of transplantation and Before desensitization, at the time of transplantation and post transplantation
Change of the percentage of "antibody secreting cells" (plasmablasts) over time
Change in Anti HLA B-cell ELISpot response
Time frame: Before desensitization, at the time of transplantation and Month 3, Month 6 and Month 12 post transplantation
Change in the number of Spot over time
Change in Flow Cytometry analyses of medullary cells
Time frame: The first day of desensitization and at the day of kidney transplantation
Change in the percentage of "antibody secreting cells" (plasmablasts) over time
Change in analyses of RNA expression on renal histology
Time frame: Month1, Month 3 and Month 12 post transplantation
CHange in percentage of gene expression using Nanostring technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by University Hospital, Grenoble.
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 21 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: status not confirmed, as of the sponsor's last update on 29 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flow Cytometry analyses of Peripheral Blood Mononuclear Cells (time frame: Before desensitization, at the time of transplantation and Before desensitization, at the time of transplantation and post transplantation). The study lists 4 primary outcomes in all. 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 Mar 2023.