Chronic Kidney DiseasesCKD-REALNCT05527626
Chronic Kidney Disease - REAL Life Study in Alsace
An observational study of Chronic Kidney Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the… 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
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2022to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Major subject (≥18 years) with a chronic renal disease
Who may be able to join
- Major subject (≥18 years)
- Subject included in the MRC package (GFR <30 ml/min/1.73 m2)
- Subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research
Who cannot join
- Subject having expressed his opposition to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France
Strasbourg, 67091
Peggy PERRIN, MD, 33 3 69 55 13 26, peggy.perrin@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry).
Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage.
Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.
- Conditions
- Chronic Kidney Diseases
- Keywords
- Kidney, Chronic Disease, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Retroanalysis of the risk factors in patients with severe chronic kidney disease
Analysis of risk factors in patients with severe chronic kidney disease by retrospectively analyzing health data contained in patient medical records
Measured: Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start17 Feb 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy PERRIN, MD, Principal investigator, Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527626
- Sponsor's protocol ID
- 8517
- Acronym
- CKD-REAL
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease - REAL Life Study in Alsace
- ClinicalTrials.gov ID
- NCT05527626
- Acronym / sponsor ID
- CKD-REAL / 8517
- Conditions
- Chronic Kidney Diseases
- Keywords
- Kidney, Chronic Disease, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Sep 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.
Chronic kidney disease (CKD) is a public health problem and affects about 10% of the world's adult population with a constantly increasing incidence. The approach to CKD in France is centered on access to replacement therapy (dialysis, renal transplantation), the cost of which amounts to 4 billion euros (data from the REIN registry).
Real-life data are essential to specify the characteristics of patients with chronic kidney disease and the factors associated with the evolution of CKD and the occurrence of complications in order to improve the management of CKD before the suppletion stage.
Since October 2019, CKD at the severe stage (stage 4) and at the non-dialysis end stage (stage 5) is subject to an annual flat fee (Article L. 162-22-6-2 of the Social Security Code). The reimbursement of these lump sums by the health insurance is subject to the collection and transmission of certain medical data by the establishments.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years) with a chronic renal disease
Key inclusion criteria (3 listed)
- Major subject (≥18 years)
- Subject included in the MRC package (GFR <30 ml/min/1.73 m2)
- Subject who has not expressed opposition, after information, to the reuse of his or her data for the purpose of this research
Key exclusion criteria (1 listed)
- Subject having expressed his opposition to participate in the study
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
Retroanalysis of the risk factors in patients with severe chronic kidney disease
Time frame: Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined
Analysis of risk factors in patients with severe chronic kidney disease by retrospectively analyzing health data contained in patient medical records
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
Saïd CHAYER, PhD, HDR contact
Peggy PERRIN, MD principal investigator
Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - 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 Diseases, run by University Hospital, Strasbourg, France 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 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: looking for participants now, as of the sponsor's last update on 9 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peggy PERRIN, MD (33 3 69 55 13 26, peggy.perrin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retroanalysis of the risk factors in patients with severe chronic kidney disease (time frame: Files analysed retrospectively from October 01, 2019 to February 31, 2027 will be examined). 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 9 Nov 2023.