Chronic Kidney DiseaseEVITUPHNCT02480699
Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients
A study testing Recurring blood sample and dietary survey in people with Chronic Kidney Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions. It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are implicated in cardiovascular complications associated with CKD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Recurring blood sample and dietary survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2015to 25 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major subjects of both sexes aged 18 and over
- Topics affiliates or beneficiaries of a social security scheme
- Haemodialysis patients whatever the etiology of renal failure for more than 3 months
- Patients not under antibiotic
- Agreeing to participate in the study and who signed a consent
- Patient able to understand a written questionnaire
Who cannot join
- Pregnant or lactating women
- Detainees
- Adults under legal protection or unable to consent
- Patient's refusal to sign the informed consent for participation
- Possibility of recovery of renal function (eg scleroderma)
- Patients carrying a replicating viral infection (HCV, HIV).
- Taking antibiotics in the previous month by 1 sampling
Trial locations and contacts
1 site in 1 country.
About this study
Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions. It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are implicated in cardiovascular complications associated with CKD. Several protein-bound toxins have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are performed with a single measurement at baseline assuming that the toxin levels are stable over time. The variability of uremic toxins level is not known. Furthermore, little is known concerning determinants of serum toxins level.
Read the detailed description
Colonic absorption play a major role in IS (indoxyl sulfate) and pCS level. IS and pCS level are significantly reduced in patient with colectomy. To validate the measurement of uremic toxins level in serum as biomarkers for cardiovascular risk, we need to know about intra-individual variability over time and the impact of diet or digestive disorders on uremic toxin serum level. We propose a prospective study evaluating the intra-individual variability in 3 uremic toxins serum levels the SI, the pCS and IAA.
The main objective is to study the kinetics of three serum uremic toxins: the indoxyl sulfate, p cresyl sulfate and indole acetic acid (and thus determine the intra-individual variability) in a population of chronic hemodialysis patients during 1 year.
- Conditions
- Chronic Kidney Disease
- Being tested
- Recurring blood sample, dietary survey
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurring blood sampleBiological
dietary surveyOther
A dietary survey will be performed in all patients and every 3 months (4 surveys about 1 year). This survey will be given to the patient filled for 7 consecutive days. He must record during these 7 days, all of his food intake in quality and quantity. During a dialysis session this questionnaire will be taken with the patient by a dietician to better define the food intake. This surveys requires good patient compliance as well as his involvement that his collection is well within its food intake.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysed patients | Experimental | Not described Receives: Biological: Recurring blood sample; Other: dietary survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of uremic toxins serum levels the SI, the pCS and IAA.
blood collection
Measured: 15 months
Secondary outcomes (1)
dietary survey
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start20 Jun 2015
- Primary completion28 Jul 2016
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480699
- Sponsor's protocol ID
- 2015-10
- Other IDs
- 2015-A00319-40, RCAPHM15_0083
- Acronym
- EVITUPH
- Status last verified
- May 2023
- First submitted
- 22 Jun 2015
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Individual Evaluation of Uremic Toxin Levels in Hemodialysed Patients
- ClinicalTrials.gov ID
- NCT02480699
- Acronym / sponsor ID
- EVITUPH / 2015-10
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 20 Jun 2015 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 24 Jun 2015 (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.
Chronic kidney disease (CKD) is characterized by a irreversible decrease of kidney functions. It is characterized by accumulation of solutes called uremic toxins. Uremic toxins levels are implicated in cardiovascular complications associated with CKD. Several protein-bound toxins have been implicated in the increased cardiovascular risk such as indoxyl sulfate (IS), p cresol sulfate (pCS) and more recently the indole acetic acid (IAA). All clinical studies are performed with a single measurement at baseline assuming that the toxin levels are stable over time. The variability of uremic toxins level is not known. Furthermore, little is known concerning determinants of serum toxins level.
Detailed description
Colonic absorption play a major role in IS (indoxyl sulfate) and pCS level. IS and pCS level are significantly reduced in patient with colectomy. To validate the measurement of uremic toxins level in serum as biomarkers for cardiovascular risk, we need to know about intra-individual variability over time and the impact of diet or digestive disorders on uremic toxin serum level. We propose a prospective study evaluating the intra-individual variability in 3 uremic toxins serum levels the SI, the pCS and IAA.
The main objective is to study the kinetics of three serum uremic toxins: the indoxyl sulfate, p cresyl sulfate and indole acetic acid (and thus determine the intra-individual variability) in a population of chronic hemodialysis patients during 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysed patients | Experimental | Biological: Recurring blood sample, Other: dietary survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Major subjects of both sexes aged 18 and over
- Topics affiliates or beneficiaries of a social security scheme
- Haemodialysis patients whatever the etiology of renal failure for more than 3 months
- Patients not under antibiotic
- Agreeing to participate in the study and who signed a consent
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Detainees
- Adults under legal protection or unable to consent
- Patient's refusal to sign the informed consent for participation
- Possibility of recovery of renal function (eg scleroderma)
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 |
|---|---|---|
| Recurring blood sample | Biological | Hemodialysed patients |
| dietary surveyA dietary survey will be performed in all patients and every 3 months (4 surveys about 1 year). This survey will be given to the patient filled for 7 consecutive days. He must record during these 7 days, all of his food intake in quality and quantity. During a dialysis session this questionnaire will be taken with the patient by a dietician to better define the food intake. This surveys requires good patient compliance as well as his involvement that his collection is well within its food intake. | Other | Hemodialysed patients |
Primary outcome
Composite measure of uremic toxins serum levels the SI, the pCS and IAA.
Time frame: 15 months
blood collection
1 secondary outcome
dietary survey
Time frame: 15 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 26 May 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.
Urielle DESALBRES, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recurring blood sample and dietary survey in people with Chronic Kidney Disease, run by Assistance Publique Hopitaux De Marseille 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 6 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 26 May 2023. 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?
Composite measure of uremic toxins serum levels the SI, the pCS and IAA. (time frame: 15 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 26 May 2023.