NCT03379571

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2009

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

6 years

First QC Date

December 4, 2017

Last Update Submit

December 15, 2017

Conditions

Keywords

Chronic kidney diseaseCompeting-risk analysisEpidemiological studyIncidenceOutcomesRisk factors

Outcome Measures

Primary Outcomes (1)

  • 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

    inclusion

Secondary Outcomes (3)

  • dialysis initiation

    through study completion, 6 year after study start

  • death

    through study completion, 6 year after study start

  • management of CKD patients

    through study completion, 6 year after study start

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \>= 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))

You may not qualify if:

  • \<18 years
  • prevalent CKD patient : CKD diagnosis before January 1st, 2004
  • patients on dialysis or renal transplanted
  • refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michèle KESSLER, PU-PH

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 20, 2017

Study Start

January 1, 2004

Primary Completion

December 31, 2009

Study Completion

December 31, 2009

Last Updated

December 20, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share