NCT04070885

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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 5, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4.2 years

First QC Date

August 22, 2019

Last Update Submit

August 26, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Estimated Glomerular Filtration Rate measurement

    by isotope technique

    At 1 year after inclusion

  • Estimated Glomerular Filtration Rate measurement

    by isotope technique

    At 2 year after inclusion

  • Measured Glomerular Filtration Rate

    by isotope technique

    At 1 year after inclusion

  • Measured Glomerular Filtration Rate

    by isotope technique

    At 2 years after inclusion

Interventions

Blood samplePROCEDURE

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 samplePROCEDURE

The urine will be taken from three 15 ml tubes.

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

A dry tube of 7 ml of blood, two 4 ml ethylene-diamine-tetra-acetic acid tubes, a 4 ml heparinized tube and an 8.5 ml citrate dextrose acid tube will be collected from the patient. The urine will be taken from three 15 ml tubes.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christian COMBE, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

January 5, 2011

Primary Completion

March 20, 2015

Study Completion

March 20, 2015

Last Updated

August 28, 2019

Record last verified: 2019-08