Chronic Renal DiseasesNéphroTestNCT04070885
Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.
An observational study of Chronic Renal Diseases and Renal Function Disorder, run by University Hospital, Bordeaux.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Diseases, Renal Function Disorder
- What is being tested?
- Blood sample and Urine sample
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2011to 20 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Chronic Renal Diseases, Renal Function Disorder
- Being tested
- Blood sample, Urine sample
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
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 or surgery
The urine will be taken from three 15 ml tubes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Glomerular Filtration Rate measurement
by isotope technique
Measured: At 1 year after inclusion
Estimated Glomerular Filtration Rate measurement
by isotope technique
Measured: At 2 year after inclusion
Measured Glomerular Filtration Rate
by isotope technique
Measured: At 1 year after inclusion
Measured Glomerular Filtration Rate
by isotope technique
Measured: At 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start5 Jan 2011
- Primary completion20 Mar 2015
- Study completion20 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian COMBE, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070885
- Sponsor's protocol ID
- CHUBX 2009/29
- Acronym
- NéphroTest
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT04070885
- Acronym / sponsor ID
- NéphroTest / CHUBX 2009/29
- Conditions
- Chronic Renal Diseases, Renal Function Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Jan 2011 (actual)
- Primary completion
- 20 Mar 2015 (actual)
- Study completion
- 20 Mar 2015 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleA 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. | Procedure or surgery | – |
| Urine sampleThe urine will be taken from three 15 ml tubes. | Procedure or surgery | – |
Primary outcome
Estimated Glomerular Filtration Rate measurement
Time frame: At 1 year after inclusion
by isotope technique
Estimated Glomerular Filtration Rate measurement
Time frame: At 2 year after inclusion
by isotope technique
Measured Glomerular Filtration Rate
Time frame: At 1 year after inclusion
by isotope technique
Measured Glomerular Filtration Rate
Time frame: At 2 years after inclusion
by isotope technique
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian COMBE, Pr principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Diseases and Renal Function Disorder, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Glomerular Filtration Rate measurement (time frame: At 1 year after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.