End-stage Chronic Kidney FailureDIALYSOXNCT02857556
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure
A study testing Blood sample, Retinal photography: and dialyse in people with End-stage Chronic Kidney Failure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-stage Chronic Kidney Failure
- What is being tested?
- Blood sample, Retinal photography: and dialyse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2014to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who have been informed about the research
- Patients with national health insurance cover
- Patients aged between 18 and 75 years
- Patients with stage 3 kidney failure (30 ml/min < cl creat < 59 ml/min) diabetic or not
- Patients with stage 5 kidney failure (cl creat < 15 ml/mn) diabetic or not and requiring dialysis.
Who cannot join
- Patients under guardianship
- Pregnant or breast-feeding women
- Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),
- Neoplastic disease,
- Systemic diseases in flare,
- Patients positive for Human Immunodeficience Virus (HIV),
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- Patients on immunosuppressants
- Patients taking antioxidants (selenium, vitamin C and/or E)
- Patient on statins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis
The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.
- Conditions
- End-stage Chronic Kidney Failure
- Being tested
- Blood sample, Retinal photography:, dialyse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Retinal photography:Other
dialyseOther
| Study group | Role | What they receive |
|---|---|---|
| group with stage 3 kidney failure (diabetic or not) | Other | Not described Receives: Biological: Blood sample; Other: Retinal photography: |
| group with stage 5 kidney failure (diabetic or not) | Other | Not described Receives: Biological: Blood sample; Other: dialyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot.
Measured: at the beginning of the period Day 0, at 1 month and at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start17 Apr 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Why it stopped: Lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Chronic Kidney FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857556
- Sponsor's protocol ID
- GAMBERT Fd. Transpl 2013
- Acronym
- DIALYSOX
- Status last verified
- May 2019
- First submitted
- 2 Aug 2016
- Last updated
- 3 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT02857556
- Acronym / sponsor ID
- DIALYSOX / GAMBERT Fd. Transpl 2013
- Conditions
- End-stage Chronic Kidney Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusions
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 17 Apr 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Aug 2016 (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 principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with stage 3 kidney failure (diabetic or not) | Other | Biological: Blood sample, Other: Retinal photography: |
| group with stage 5 kidney failure (diabetic or not) | Other | Biological: Blood sample, Other: dialyse |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who have been informed about the research
- Patients with national health insurance cover
- Patients aged between 18 and 75 years
- Patients with stage 3 kidney failure (30 ml/min < cl creat < 59 ml/min) diabetic or not
- Patients with stage 5 kidney failure (cl creat < 15 ml/mn) diabetic or not and requiring dialysis.
Key exclusion criteria (9 listed)
- Patients under guardianship
- Pregnant or breast-feeding women
- Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),
- Neoplastic disease,
- Systemic diseases in flare,
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 sample | Biological | group with stage 3 kidney failure (diabetic or not), group with stage 5 kidney failure (diabetic or not) |
| Retinal photography: | Other | group with stage 3 kidney failure (diabetic or not) |
| dialyse | Other | group with stage 5 kidney failure (diabetic or not) |
Primary outcome
Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot.
Time frame: at the beginning of the period Day 0, at 1 month and at 3 months.
Results and safety
The study was stopped early (reason given: Lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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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.
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, Retinal photography: and dialyse in people with End-stage Chronic Kidney Failure, run by Centre Hospitalier Universitaire Dijon 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 May 2019. 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 was stopped early (reason given: Lack of inclusions). 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?
Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot. (time frame: at the beginning of the period Day 0, at 1 month and at 3 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 3 May 2019.