Competing Risk of Death and ESRD in Incident CKD Patients

Chronic Kidney Diseases Clinical Trial

— EPIRAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379571
• Other study ID #: EPIRAN1
• Status: Completed
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 15, 2017
• Start date: January 1, 2004
• Est. completion date: December 31, 2009

Study information

• Verified date: December 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 631
• Est. completion date: December 31, 2009
• Est. primary completion date: December 31, 2009
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	dialysis initiation	number of dialysis initiation.	through study completion, 6 year after study start
Secondary	death	number of death	through study completion, 6 year after study start
Secondary	management of CKD patients	%patients referred to a nephrologist, decline of the renal function	through study completion, 6 year after study start