Renal FailureIRISNCT02116270
Accelerated Immunosenescence and Chronic Kidney Disease
A study testing Blood sample in people with Renal Failure, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jan 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient able to understand the reason of the study
- Patient not opposed to the conservation of biological samples for scientific research
Who cannot join
- Patient suffering from psychotic illness
- Any history of immunosuppressive therapy (except steroids up to 5mg/day)
- History of cancer (except skin cancer) or treated hematological malignancy
- Infectious episode required hospitalization not older 3 months
- Hepatitis B or C infection
- HIV infection, active or inactive
- For dialysis patients: renal failure on dialysis for less than 3 months and/or have benefited from two techniques for renal replacement therapy in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes.
Read the detailed description
The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation. Kidney disease is associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine response and increased susceptibility to infections, similar to those observed in the elderly population.
However, data on aging of the immune system in chronic kidney disease remains incomplete. Furthermore, the determinants of immunosenescence are not also not known. It is possible that "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact.
The purpose of this study is to describe the phenotypes of the immune system of renal and analyze the determinants of these changes.
- Conditions
- Renal Failure
- Being tested
- Blood sample
- Keywords
- Renal Failure, Dialysis, Biological Aging
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Patients in this group control (normal renal function) are followed in the urology department. A blood sample is performed on the day of inclusion. Receives: Biological: Blood sample |
| Severe renal failure | Experimental | Patients in this group suffer from renal failure stage 4 and are not under dialysis. A blood sample is performed on the day of inclusion. Receives: Biological: Blood sample |
| Peritoneal dialysis | Experimental | Patients with renal failure, under peritoneal dialysis for at least 3 months. A blood sample is performed on the day of inclusion. Receives: Biological: Blood sample |
| Hemodialysis | Experimental | Patient with renal failure, under hemodialysis for at least 3 months. A blood sample is performed on the day of inclusion. Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes)
The primary outcome measure is the percentage of CD 4/8+ CD 57+ CD 28- lymphocytes by flow cytometry. The technique used is a 6 colors surface labelling of T lymphocytes to study the T cell senescent population.
Measured: 6 months
Secondary outcomes (5)
Telomerase Activity of T lymphocytes
The telomerase activity of T lymphocytes is assessed by a method of Polymerase chain reaction (PCR)-ELISA.
Measured: 6 months
Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes
This level is obtained by flow cytometry after permeabilization and labelling of Peripheral Blood Mononuclear Cells (PBMC).
Measured: 6 months
Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes
RTE T cells will be defined by flow cytometry, according to co-expression of CD 4, CD 8,CD 31 and CD 45RA
Measured: 6 months
T-cell receptor excision circle (TREC) level in PBMC.
TRECs study is based on a technique of quantitative PCR using DNA extracted from PBMC.
Measured: 6 months
Telomere length in T lymphocytes
Study of telomere length is performed after extraction of DNA from isolated T cells. The length is determined by a quantitative PCR technique relative to a reference gene.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamal BAMOULID, Doctor, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116270
- Sponsor's protocol ID
- IRIS API/2012/28
- Acronym
- IRIS
- Status last verified
- Aug 2016
- First submitted
- 9 Apr 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Immunosenescence and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02116270
- Acronym / sponsor ID
- IRIS / IRIS API/2012/28
- Conditions
- Renal Failure
- Keywords
- Renal Failure, Dialysis, Biological Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes.
Detailed description
The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation. Kidney disease is associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine response and increased susceptibility to infections, similar to those observed in the elderly population.
However, data on aging of the immune system in chronic kidney disease remains incomplete. Furthermore, the determinants of immunosenescence are not also not known. It is possible that "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact.
The purpose of this study is to describe the phenotypes of the immune system of renal and analyze the determinants of these changes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Biological: Blood samplePatients in this group control (normal renal function) are followed in the urology department. A blood sample is performed on the day of inclusion. |
| Severe renal failure | Experimental | Biological: Blood samplePatients in this group suffer from renal failure stage 4 and are not under dialysis. A blood sample is performed on the day of inclusion. |
| Peritoneal dialysis | Experimental | Biological: Blood samplePatients with renal failure, under peritoneal dialysis for at least 3 months. A blood sample is performed on the day of inclusion. |
| Hemodialysis | Experimental | Biological: Blood samplePatient with renal failure, under hemodialysis for at least 3 months. A blood sample is performed on the day of inclusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient able to understand the reason of the study
- Patient not opposed to the conservation of biological samples for scientific research
Key exclusion criteria (7 listed)
- Patient suffering from psychotic illness
- Any history of immunosuppressive therapy (except steroids up to 5mg/day)
- History of cancer (except skin cancer) or treated hematological malignancy
- Infectious episode required hospitalization not older 3 months
- Hepatitis B or C infection
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 sample3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0. | Biological | Control group, Hemodialysis, Peritoneal dialysis, Severe renal failure |
Primary outcome
Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes)
Time frame: 6 months
The primary outcome measure is the percentage of CD 4/8+ CD 57+ CD 28- lymphocytes by flow cytometry. The technique used is a 6 colors surface labelling of T lymphocytes to study the T cell senescent population.
5 secondary outcomes
Telomerase Activity of T lymphocytes
Time frame: 6 months
Level of phospho-histone 2AX (gH2AX) in peripheral blood T lymphocytes
Time frame: 6 months
Proportion of Recent Thymic Emigrants (RTE) in peripheral blood T lymphocytes
Time frame: 6 months
T-cell receptor excision circle (TREC) level in PBMC.
Time frame: 6 months
Telomere length in T lymphocytes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Jamal BAMOULID, Doctor principal investigator
CHU de Besançon
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 sample in people with Renal Failure, run by Centre Hospitalier Universitaire de Besancon 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 5 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Cluster of Differentiation (CD) 4/8+ CD 57+ CD 28- lymphocytes (senescent lymphocytes) (time frame: 6 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 5 Apr 2018.