Chronic Kidney Disease 5DREFILBIOADMNCT05339009
Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient
An observational study of Chronic Kidney Disease 5D, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease 5D
- What is being tested?
- BioADM determination in plasma
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 1 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients issued from dialysis units (non profit dialysis centers)
Who may be able to join
- Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
- Anuric patient
Who cannot join
- Patient protected by law
- Patient under guardianship ou curatorship
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier
Jean-Yves BOSC, 430 781 868 ext. 33, j.bosc@aidersante.com
Lotfi CHALABI, 430 781 868 ext. 33, l.chalabi@aidersante.com
About this study
Official title: Bio-adrenomedullin (Bio-ADM) as a Biomarker of Refilling in Chronic Hemodialysis Patient
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.
- Conditions
- Chronic Kidney Disease 5D
- Being tested
- BioADM determination in plasma
- Keywords
- Chronic kidney disease, Extracorporeal purification, Bio-ADM, Vascular refilling rate
- 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.
BioADM determination in plasmaBiological
BioADM determination in plasma
| Study group | Role | What they receive |
|---|---|---|
| All patients receive conventional dialysis treatment at inclusion | All patients receive conventional dialysis treatment at inclusion Receives: Biological: BioADM determination in plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between bio-ADM level and vascular refilling rate
The refilling rate will be assessed by the ratio of relative blood volume and UF max
Measured: Day 1
Secondary outcomes (1)
Bio-ADM value according to comorbidity factors
Bio-ADM value according to comorbidity factors (diabetes, heart failure and low-grade inflammation)
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 Apr 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, MD PhD, Principal investigator, University Hospital Center of Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339009
- Sponsor's protocol ID
- RECHMPL21_0068
- Acronym
- REFILBIOADM
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-adrenomedullin (Bio-ADM) as a Biomarker of Refilling in Chronic Hemodialysis Patient
- ClinicalTrials.gov ID
- NCT05339009
- Acronym / sponsor ID
- REFILBIOADM / RECHMPL21_0068
- Conditions
- Chronic Kidney Disease 5D
- Keywords
- Chronic kidney disease, Extracorporeal purification, Bio-ADM, Vascular refilling rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 21 Apr 2022 (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.
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients receive conventional dialysis treatment at inclusion | – | Biological: BioADM determination in plasmaAll patients receive conventional dialysis treatment at inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients issued from dialysis units (non profit dialysis centers)
Key inclusion criteria (2 listed)
- Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
- Anuric patient
Key exclusion criteria (3 listed)
- Patient protected by law
- Patient under guardianship ou curatorship
- Patient deprived of liberty
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 |
|---|---|---|
| BioADM determination in plasmaBioADM determination in plasma | Biological | All patients receive conventional dialysis treatment at inclusion |
Primary outcome
Relationship between bio-ADM level and vascular refilling rate
Time frame: Day 1
The refilling rate will be assessed by the ratio of relative blood volume and UF max
1 secondary outcome
Bio-ADM value according to comorbidity factors
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 21 Apr 2022.
- Individual participant dataSharing planned: No
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Chronic Kidney Disease 5D
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.
Jean-Paul CRISTOL, MD PhD principal investigator
University Hospital Center of Montpellier, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease 5D, run by University Hospital, Montpellier 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 3 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 21 Apr 2022. 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 Jean-Paul CRISTOL, MD PhD (+33 467 338315, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between bio-ADM level and vascular refilling rate (time frame: Day 1). 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 21 Apr 2022.