Chronic Kidney Disease stage4FAIR-PROGRESSNCT03954470
Factors Influencing Risk of Progression of Chronic Kidney Disease
An observational study of Chronic Kidney Disease stage4, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease stage4
- How many people
- 1,300 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2012to 31 Dec 2018
- 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: Adult population with chronic renal failure, before replacement therapy, followed in 9 nephrology departments of Bourgogne Franche-Comté.
Who may be able to join
- Patients meeting the inclusion criteria of the ND-CRIS cohort (long-term follow-up in one of the centers participating in the research, with a GFR <60mL/min /1.73m2)
- Patients included in the ND-CRIS cohort on the date when the estimate of their GFR is strictly less than 30mL/min/1.73m2 and greater than or equal to 15mL/min/1.73m2 (MDRD equation).
- Patients should have at least two measurements of GFR <30mL/min/1.73m2 to be included, at least one of them greater than or equal to 15mL/min/1.73m2. The date of the first GFR <30mL/min/ 1.73m2 will be considered as the date of origin.
Who cannot join
- Patients with GFR ≥30mL / min / 1.73m2 or <15mL / min / 1.73m2
- Patients who do not meet the inclusion criteria of ND-CRIS cohort (dialysis patients, transplant patients, unfollowed patients)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Influencing Risk of Progression of Chronic Kidney Disease in Patients With Severe Renal Failure
The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.
- Conditions
- Chronic Kidney Disease stage4
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of estimated Glomerular Filtration Rate (GFR) according to MDRD equation (modification of diet in renal disease) at each visit
Measured: up to 3 years
Time between inclusion and occurrence of the "progression" event
progression: initiation of an extra-renal purification technique or reduction of GFR of at least 5 mL / min / 1.73m2 compared to inclusion in FAIR-PROGRESS
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start9 Apr 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage4Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954470
- Sponsor's protocol ID
- API/2017/87
- Acronym
- FAIR-PROGRESS
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Risk of Progression of Chronic Kidney Disease in Patients With Severe Renal Failure
- ClinicalTrials.gov ID
- NCT03954470
- Acronym / sponsor ID
- FAIR-PROGRESS / API/2017/87
- Conditions
- Chronic Kidney Disease stage4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 Apr 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 May 2019 (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.
The aim of this study is to identify typical patterns of renal function evolution in patients with stage 4 chronic kidney disease, regularly followed in nephrology consultation and included in a French cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with chronic renal failure, before replacement therapy, followed in 9 nephrology departments of Bourgogne Franche-Comté.
Key inclusion criteria (3 listed)
- Patients meeting the inclusion criteria of the ND-CRIS cohort (long-term follow-up in one of the centers participating in the research, with a GFR <60mL/min /1.73m2)
- Patients included in the ND-CRIS cohort on the date when the estimate of their GFR is strictly less than 30mL/min/1.73m2 and greater than or equal to 15mL/min/1.73m2 (MDRD equation).
- Patients should have at least two measurements of GFR <30mL/min/1.73m2 to be included, at least one of them greater than or equal to 15mL/min/1.73m2. The date of the first GFR <30mL/min/ 1.73m2 will be considered as the date of origin.
Key exclusion criteria (2 listed)
- Patients with GFR ≥30mL / min / 1.73m2 or <15mL / min / 1.73m2
- Patients who do not meet the inclusion criteria of ND-CRIS cohort (dialysis patients, transplant patients, unfollowed patients)
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
Evolution of estimated Glomerular Filtration Rate (GFR) according to MDRD equation (modification of diet in renal disease) at each visit
Time frame: up to 3 years
Time between inclusion and occurrence of the "progression" event
Time frame: up to 3 years
progression: initiation of an extra-renal purification technique or reduction of GFR of at least 5 mL / min / 1.73m2 compared to inclusion in FAIR-PROGRESS
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 17 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?
An observational study of Chronic Kidney Disease stage4, 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 3 inclusion and 2 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 17 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 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?
Evolution of estimated Glomerular Filtration Rate (GFR) according to MDRD equation (modification of diet in renal disease) at each visit (time frame: up to 3 years). The study lists 2 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 17 May 2019.