Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease. (NéphroTest)

August 26, 2019 updated by: University Hospital, Bordeaux
This study aims to conduct a prospective collection of clinical and para-clinical data in patients with Chronic Renal Diseases to identify disease progression factors, markers of renal function, and the pathophysiology of Chronic Renal Diseases complications.

Study Overview

Detailed Description

Chronic Renal Diseases have a growing incidence and prevalence in France, with significant consequences in terms of morbidity and mortality, especially cardiovascular, and Public Health.

It is necessary to know better:

  • the mechanisms leading to the progression of the Chronic Renal Diseases
  • markers to quantify renal function and progression of the Chronic Renal Diseases
  • the pathophysiology of Chronic Renal Diseases complications, cardiovascular, nutritional, or mineral metabolism in particular.

This study aims to conduct a prospective collection of clinical and para-clinical data in patients with Chronic Renal Diseases to identify disease progression factors, markers of renal function, and the pathophysiology of Chronic Renal Diseases complications.

Study Type

Observational

Enrollment (Actual)

210

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participation in NephroTest will be offered to eligible patients by the doctors of the Nephrology Department, during consultations or as a result of hospitalization.

Description

Inclusion Criteria:

  • Patients with Chronic Renal Disease, stage 2 to 5, non-dialysis patients over the age of 18,
  • followed in the Nephrology Department of the Bordeaux University Hospital
  • agreeing to participate in NephroTest
  • affiliated with social security.

Exclusion Criteria:

  • Patients under 18 years
  • Patients with acute or rapidly progressive renal failure
  • Patients with severe comorbidities or comorbidities that are life-threatening in the short term (<1 year)
  • Patients who did not give their written consent to be included in the study
  • Major incapacitated patients and psychiatric patients admitted to hospital

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
Estimated Glomerular Filtration Rate measurement
Time Frame: At 1 year after inclusion
by isotope technique
At 1 year after inclusion
Estimated Glomerular Filtration Rate measurement
Time Frame: At 2 year after inclusion
by isotope technique
At 2 year after inclusion
Measured Glomerular Filtration Rate
Time Frame: At 1 year after inclusion
by isotope technique
At 1 year after inclusion
Measured Glomerular Filtration Rate
Time Frame: At 2 years after inclusion
by isotope technique
At 2 years after inclusion

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Christian COMBE, Pr, University Hospital, Bordeaux

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 5, 2011

Primary Completion (Actual)

March 20, 2015

Study Completion (Actual)

March 20, 2015

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CHUBX 2009/29

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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