Chronic Kidney DiseasesREMVAMIRNCT04810338
Study Evaluating the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis
An observational study of Chronic Kidney Diseases, 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) during an observational period of 3 years: the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number the prognostic value of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Sep 2021
- 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) since at least september 2017 (3 months prior to study start date)
- Anuric patient
Who cannot join
- Chronic Kidney Disease patient on dialysis with residual kidney function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) during an observational period of 3 years:
- the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
- the prognostic value of interdialytic weight gain on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
- the prognostic value of perdialytic weight loss on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number.
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Sodium
- 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.
| Study group | Role | What they receive |
|---|---|---|
| All patients received conventional dialysis treatment | All patients received conventional dialysis treatment during an observational period of 3 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of vascular refilling rate on mortality
The refilling rate will be assessed by the ratio of relative blood volume
Measured: 2 years after inclusion
Prognostic value of vascular refilling rate on mortality
The refilling rate will be assessed by the ratio of relative blood volume
Measured: 3 years after inclusion
Prognostic value of vascular refilling rate on mortality
The refilling rate will be assessed by the ratio UF max
Measured: 3 years after inclusion
Prognostic value of vascular refilling rate on mortality
The refilling rate will be assessed by the ratio UF max
Measured: 2 years after inclusion
Secondary outcomes (4)
Prognostic value of interdialytic weight gain
Prognostic value of interdialytic weight gain
Measured: 2 years after inclusion
Prognostic value of interdialytic weight gain
Prognostic value of interdialytic weight gain
Measured: 3 years after inclusion
Prognostic value of perdialytic weight loss
Prognostic value of perdialytic weight loss
Measured: 2 years after inclusion
Prognostic value of perdialytic weight loss
Prognostic value of perdialytic weight loss
Measured: 3 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jan 2018
- Primary completion1 Dec 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810338
- Sponsor's protocol ID
- RECHMPL20_0660
- Acronym
- REMVAMIR
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
- ClinicalTrials.gov ID
- NCT04810338
- Acronym / sponsor ID
- REMVAMIR / RECHMPL20_0660
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Sodium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Mar 2021 (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) during an observational period of 3 years:
- the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
- the prognostic value of interdialytic weight gain on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
- the prognostic value of perdialytic weight loss on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients received conventional dialysis treatment | – | –All patients received conventional dialysis treatment during an observational period of 3 years |
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) since at least september 2017 (3 months prior to study start date)
- Anuric patient
Key exclusion criteria (1 listed)
- Chronic Kidney Disease patient on dialysis with residual kidney function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic value of vascular refilling rate on mortality
Time frame: 2 years after inclusion
The refilling rate will be assessed by the ratio of relative blood volume
Prognostic value of vascular refilling rate on mortality
Time frame: 3 years after inclusion
The refilling rate will be assessed by the ratio of relative blood volume
Prognostic value of vascular refilling rate on mortality
Time frame: 3 years after inclusion
The refilling rate will be assessed by the ratio UF max
Prognostic value of vascular refilling rate on mortality
Time frame: 2 years after inclusion
The refilling rate will be assessed by the ratio UF max
4 secondary outcomes
Prognostic value of interdialytic weight gain
Time frame: 2 years after inclusion
Prognostic value of interdialytic weight gain
Time frame: 3 years after inclusion
Prognostic value of perdialytic weight loss
Time frame: 2 years after inclusion
Prognostic value of perdialytic weight loss
Time frame: 3 years after inclusion
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 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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, Prof study director
UH MONTPELLIER
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 Diseases, 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 1 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 14 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?
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?
Prognostic value of vascular refilling rate on mortality (time frame: 2 years after inclusion). The study lists 4 primary outcomes in all. 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 14 Apr 2022.