Chronic Kidney DiseasesEPIRANNCT03379571
Competing Risk of Death and ESRD in Incident CKD Patients
An observational study of Chronic Kidney Diseases, run by Central Hospital, Nancy, France.
Trial summary
Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data on incident CKD in the general population are scarce. Screening strategies to increase early CKD detection have been developed. 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
- 631 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 31 Dec 2009
- 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
- Adult, Older adult
Study population: The study population was incident CKD patients (stages 3 to 5) : all adult patients (≥18 years) residing in the given geographical area and having a first serum creatinine value ≥1.7 mg/dL reached after January 1st, 2004 and present for at least 3 months.
Who may be able to join
- >= 18 years
- first serum creatinine value ≥1.7 mg/dL reached after January 1st, 2004
- and present for at least 3 months
- residing in the given geographical area (the Urban Community of Greater Nancy (UCGN))
Who cannot join
- <18 years
- prevalent CKD patient : CKD diagnosis before January 1st, 2004
- patients on dialysis or renal transplanted
- refusal of participation
About this study
Official title: Competing Risk of Death and End-stage Renal Disease in Incident Chronic Kidney Disease (Stages 3 to 5): the EPIRAN Community-based Study
Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data on incident CKD in the general population are scarce. Screening strategies to increase early CKD detection have been developed.
Methods: From a community-based sample of 4,409 individuals residing in a well-defined geographical area, investigators determined the number of patients having a first serum creatinine value ≥1.7 mg/dL and present for at least 3 months that allowed us to calculate an annual incidence rate of CKD (stages 3 to 5). CKD (stages 3 to 5) was defined by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Investigators also described the primary care, outcomes and risk factors associated with outcomes using competing risks analyses for these CKD patients.
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic kidney disease, Competing-risk analysis, Epidemiological study, Incidence, Outcomes, Risk factors
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
annual incidence rate of CKD
number of patients residing in a well-defined geographical area having a first serum creatinine value ≥1.7 mg/dL after January 1st, 2004 and still present for at least 3 months
Measured: inclusion
Secondary outcomes (3)
dialysis initiation
number of dialysis initiation.
Measured: through study completion, 6 year after study start
death
number of death
Measured: through study completion, 6 year after study start
management of CKD patients
%patients referred to a nephrologist, decline of the renal function
Measured: through study completion, 6 year after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2004
- Primary completion31 Dec 2009
- Study completion31 Dec 2009
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 Central Hospital, Nancy, 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle KESSLER, PU-PH, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379571
- Sponsor's protocol ID
- EPIRAN1
- Acronym
- EPIRAN
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 20 Dec 2017
- 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 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Competing Risk of Death and End-stage Renal Disease in Incident Chronic Kidney Disease (Stages 3 to 5): the EPIRAN Community-based Study
- ClinicalTrials.gov ID
- NCT03379571
- Acronym / sponsor ID
- EPIRAN / EPIRAN1
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic kidney disease, Competing-risk analysis, Epidemiological study, Incidence, Outcomes, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 20 Dec 2017 (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.
Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data on incident CKD in the general population are scarce. Screening strategies to increase early CKD detection have been developed.
Methods: From a community-based sample of 4,409 individuals residing in a well-defined geographical area, investigators determined the number of patients having a first serum creatinine value ≥1.7 mg/dL and present for at least 3 months that allowed us to calculate an annual incidence rate of CKD (stages 3 to 5). CKD (stages 3 to 5) was defined by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Investigators also described the primary care, outcomes and risk factors associated with outcomes using competing risks analyses for these CKD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population was incident CKD patients (stages 3 to 5) : all adult patients (≥18 years) residing in the given geographical area and having a first serum creatinine value ≥1.7 mg/dL reached after January 1st, 2004 and present for at least 3 months.
Key inclusion criteria (4 listed)
- >= 18 years
- first serum creatinine value ≥1.7 mg/dL reached after January 1st, 2004
- and present for at least 3 months
- residing in the given geographical area (the Urban Community of Greater Nancy (UCGN))
Key exclusion criteria (4 listed)
- <18 years
- prevalent CKD patient : CKD diagnosis before January 1st, 2004
- patients on dialysis or renal transplanted
- refusal of participation
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
annual incidence rate of CKD
Time frame: inclusion
number of patients residing in a well-defined geographical area having a first serum creatinine value ≥1.7 mg/dL after January 1st, 2004 and still present for at least 3 months
3 secondary outcomes
dialysis initiation
Time frame: through study completion, 6 year after study start
death
Time frame: through study completion, 6 year after study start
management of CKD patients
Time frame: through study completion, 6 year after study start
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 20 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Michèle KESSLER, PU-PH principal investigator
CHRU de Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Central Hospital, Nancy, 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 4 inclusion and 4 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
annual incidence rate of CKD (time frame: inclusion). 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 20 Dec 2017.