Competing Risk of Death and ESRD in Incident CKD Patients (EPIRAN)

December 15, 2017 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • >= 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))

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dialysis initiation
Time Frame: through study completion, 6 year after study start
number of dialysis initiation.
through study completion, 6 year after study start
death
Time Frame: through study completion, 6 year after study start
number of death
through study completion, 6 year after study start
management of CKD patients
Time Frame: through study completion, 6 year after study start
%patients referred to a nephrologist, decline of the renal function
through study completion, 6 year after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Michèle KESSLER, PU-PH, CHRU de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2004

Primary Completion (Actual)

December 31, 2009

Study Completion (Actual)

December 31, 2009

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2017

Last Update Submitted That Met QC Criteria

December 15, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIRAN1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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