End-stage Renal DiseaseECLATNCT03994497
Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation
A study testing Blood samples in people with End-stage Renal Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2021to 2 Feb 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 and under 70 years old
- Patients in care for a first priority renal transplant.
- Patients with low immunological risk
- Patients with prior written informed consent
Who cannot join
- Poor understanding of the French language
- Pregnant, breastfeeding or partying women
- Persons deprived of liberty by an administrative or judicial decision
- Persons undergoing psychiatric care under duress
- Adults who are subject to a legal or non-state protection measure to express their consent
Trial locations and contacts
1 site in 1 country.
Béatrice GABLE contact
France1 site, 1 recruiting
- Recruiting
Dr Anne-Sophie GARNIER
Angers
Anne-Sophie GARNIER, Dr, 2 41 35 44 76 ext. +33, annesophie.garnier@chu-angers.fr
About this study
Chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. Despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival.
Different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (HLA) incompatibilities between the donor and the recipient. However, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies.
Read more
Also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation.
The onset of acute rejection is caused by the ability of the recipient's T cells to recognize alloantigens. The CD45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the T cell.
Investigators showed that the level of expression of CD45RC on T lymphocytes was associated with the risk of acute rejection. Thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating CD8 lymphocytes expressing high CD45RC (CD45RChigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of CD8+CD45RChigh.
The purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.
- Conditions
- End-stage Renal Disease
- Being tested
- Blood samples
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples the day of the surgery and 4 times during the next year. Blood samples and histological slides taken at each biopsy and if there is suspicion of rejection of the graft
| Study group | Role | What they receive |
|---|---|---|
| Patient in need of a kidney transplant | Other | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy
Measured: 12 months
Secondary outcomes (6)
Rate of CD45RC for patient with acute rejection suspicion
acute rejection confirmed or not
Measured: 12 months
Rate of CD45RC on circulating T lymphocytes
Evolution of the expression of CD45RC in the first year after introduction of immunosuppressive therapy
Measured: from date of randomization until the date of acute rejection, up to 12 months
Rate of CD45RC on circulating T lymphocytes the day of acute rejection
day of acute rejection
Measured: 12 months
Rate of CD4, CD8, CD45RA, CD25, CD127, CD19 markers on T cells the day of acute rejection
day of acute rejection
Measured: 12 months
anti-HLA antibodies' dosage at the time of acute rejection
Measured: 12 months
cytokines' dosage
describe cytokine profile
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start3 Feb 2021
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994497
- Sponsor's protocol ID
- 49RC18_0018
- Acronym
- ECLAT
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2019
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Level of Expression of CD45RC on T Lymphocytes as a Predictive Biomarker of Acute Rejection After Renal Transplantation
- ClinicalTrials.gov ID
- NCT03994497
- Acronym / sponsor ID
- ECLAT / 49RC18_0018
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 21 Jun 2019 (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 renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in France - and its socio-economic impact. At the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. Despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival.
Different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (HLA) incompatibilities between the donor and the recipient. However, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies.
Also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation.
The onset of acute rejection is caused by the ability of the recipient's T cells to recognize alloantigens. The CD45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the T cell.
Investigators showed that the level of expression of CD45RC on T lymphocytes was associated with the risk of acute rejection. Thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating CD8 lymphocytes expressing high CD45RC (CD45RChigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of CD8+CD45RChigh.
The purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in need of a kidney transplant | Other | Other: Blood samples |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 and under 70 years old
- Patients in care for a first priority renal transplant.
- Patients with low immunological risk
- Patients with prior written informed consent
Key exclusion criteria (5 listed)
- Poor understanding of the French language
- Pregnant, breastfeeding or partying women
- Persons deprived of liberty by an administrative or judicial decision
- Persons undergoing psychiatric care under duress
- Adults who are subject to a legal or non-state protection measure to express their consent
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 samplesBlood samples the day of the surgery and 4 times during the next year. Blood samples and histological slides taken at each biopsy and if there is suspicion of rejection of the graft | Other | Patient in need of a kidney transplant |
Primary outcome
Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy
Time frame: 12 months
6 secondary outcomes
Rate of CD45RC for patient with acute rejection suspicion
Time frame: 12 months
Rate of CD45RC on circulating T lymphocytes
Time frame: from date of randomization until the date of acute rejection, up to 12 months
Rate of CD45RC on circulating T lymphocytes the day of acute rejection
Time frame: 12 months
Rate of CD4, CD8, CD45RA, CD25, CD127, CD19 markers on T cells the day of acute rejection
Time frame: 12 months
anti-HLA antibodies' dosage at the time of acute rejection
Time frame: 12 months
cytokines' dosage
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
Béatrice GABLE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with End-stage Renal Disease, run by University Hospital, Angers at 1 site 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 4 inclusion and 5 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie GARNIER, MD (0241356075 ext. +33, AnneSophie.Garnier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with acute rejection diagnosis confirmed by anatomopathological analysis of a graft biopsy (time frame: 12 months). 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 11 Jun 2024.