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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04070885
Other study ID # CHUBX 2009/29
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2011
Est. completion date March 20, 2015

Study information

Verified date August 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date March 20, 2015
Est. primary completion date March 20, 2015
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Blood sample
A dry tube of 7 ml of blood, two 4 ml EDTA tubes, a 4 ml heparinized tube and an 8.5 ml ACD-A tube will be collected from the patient.
Urine sample
The urine will be taken from three 15 ml tubes.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated Glomerular Filtration Rate measurement by isotope technique At 1 year after inclusion
Primary Estimated Glomerular Filtration Rate measurement by isotope technique At 2 year after inclusion
Primary Measured Glomerular Filtration Rate by isotope technique At 1 year after inclusion
Primary Measured Glomerular Filtration Rate by isotope technique At 2 years after inclusion
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