Chronic Kidney DiseasesPRECIMETABNCT05307172
Precision Medicine Approach to Unravel the Risk Factors for Renal, Cardiovascular, Ophthalmologic, Neurologic and Hepatic Complications of Metabolic Disorders
An observational study of Chronic Kidney Diseases and Diabetes, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
There is currently no way to predict the progression of chronic kidney disease in patients with metabolic disease(s). Furthermore, the mechanisms responsible for the development and/or progression of complications remain largely unknown. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes, Obesity
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2022to 3 May 2032
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, suffering from obesity and/or diabetes and presenting signs of renal parenchymal suffering, referred to the Amiens-Picardie University Hospital for monitoring of the renal function and screening in primary prevention of associated neurological, hepatic and cardiovascular comorbidities.
Who may be able to join
- Adult persons, male or female, age ≥ 18 and ≤ 65 years
- Persons able to understand the information provided and to object to it (at the discretion of the investigator)
- Patient affiliated to a social security system.
- Patient willing to sign an informed consent form
- Patient with the following metabolic profile Diabetic (of any type) treated or not (diabetes will be defined by a fasting blood glucose > 7mM or a HbA1c > 6.5% or by the use of an antidiabetic treatment) AND/OR Obese patient (BMI > 30 kg/m2) treated or not
- Patient with evidence of renal parenchymal damage defined by an albuminuria/creatinuria ratio ≥ 3 mg/mmol (30mg/g), AND/OR a glomerular filtration rate estimated by the CKD-EPI (eDFG) formula classifying the patient as stage 2 to 3a of the KDIGO classification (i.e., 90ml/min/1.73 m2 > GFR > 45ml/min), AND/OR a renal lithiasis
Who cannot join
- Patient deprived of liberty
- Person subject to a legal protection measure (guardianship, curatorship or safeguard of justice)
- Patient refusing to participate in the study
- Pregnant, parturient or nursing woman
- Patient in emergency situation
- Patient with advanced chronic kidney disease defined as GFR < 45ml/min/1.73 m².
- Contraindication to Iohexol injection
- Patient with or who has had any of the following complications: symptomatic coronary artery disease, symptomatic peripheral arterial disease, previous stroke, previous myocardial infarction, heart failure ≥ stage B, dementia, liver fibrosis, hepatocarcinoma.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire d'AMIENS - Picardie
Amiens, 80054
About this study
There is currently no way to predict the progression of chronic kidney disease in patients with metabolic disease(s). Furthermore, the mechanisms responsible for the development and/or progression of complications remain largely unknown.
In order to identify the predictive factors and/or mechanisms involved in the different complications of these diseases, we propose an approach coupling :
Read more
- a classical phenotypic characterization (clinical, biological, imaging) of the patients
- high-throughput screening of the genome, transcriptome, metabolome, proteome, and immunophenotyping.
According to our hypothesis, this approach should allow :
- Early detection of complications
- Classification of patients in homogeneous groups of patients with identical evolution
- Identification of the molecular mechanisms involved.
Read the detailed description
Eligible patients will be detected during one of their consultations at the precision medicine center of the Amiens-Picardy University Hospital. They will be informed of the proposed research pathway during a care consultation. After a period of reflection, patients who accept this pathway will be included and a written consent form will be collected.
The inclusion visit will be scheduled at the precision medicine center of the Amiens-Picardy University Hospital and will take place during a day hospital (HDJ) which is part of a routine care pathway (neurological, cardiovascular, hepatic and renal primary prevention). At the time of inclusion, the informed consent will be signed by the investigator as well as by the patient The collection of data obtained during the patient's routine care will be performed by a physician from the Precision Medicine Center and a clinical research nurse and will be recorded in the patient's medical record.
Biological samples for the research (additional blood volume, urine) will be taken in conjunction with those for the routine check-up.
A hair strand of approximately 100 hairs (approx. 2 mm diameter) will be collected at the inclusion visit. This sample will be optional and will be subject to a specific authorization from the patient on the consent form.
Biological samples intended for research will be sent by the department's staff to the Biobank of Picardie (CHU Amiens-Picardie) for processing and storage.
The follow-up of the patient will be done strictly within the framework of his care adapted to his pathology. No visits will be made specifically for research purposes. The schedule of follow-up visits for the study corresponds to the visits usually scheduled as part of patient care: at 1 year after the inclusion visit (A1), at 4 years (A4) and at 7 years (A7).
In summary: One year after the inclusion visit, the patient will have a clinical and biological evaluation including a measurement of renal function to determine the rate of decline of glomerular filtration rate in order to classify the patient as a non-progressor, a moderate-progressor, or a rapid-progressor (see primary endpoints). The rate of decline of GFR will be correlated with clinical, biological, genetic and environmental data collected at patient inclusion, by means of dedicated questionnaires, biological results collected and analyses performed on research samples taken during the patient inclusion visit. The prognostic power of the classic clinical and biological criteria and of the new biomarkers discovered during the study to predict the patient's all-cause evolutionary profile will be evaluated́ by hazard ratio and 95% confidence interval. This reassessment will then be repeated at each visit until the end of the study.
Follow-up visits will be conducted in the same manner as the inclusion visit. The collection of data obtained during the routine care follow-up will be performed by a Precision Medicine Center physician and a clinical research nurse and will be recorded in the patient's medical record.
Additional biological samples (additional volume of blood, urine) will be taken during the care samples to meet the research objectives.
The occurrence of a pregnancy during the follow-up period will not constitute an exclusion criterion. The patient will be able to continue her participation in the study.
Failure to complete one of the follow-up visits will not be considered an early exit from the research. The patient will be scheduled for the next protocol visit.
- Conditions
- Chronic Kidney Diseases, Diabetes, Obesity
- Keywords
- Chronic Kidney Diseases, Diabetes, Precision Medicine, Biomarkers
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance
The rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance, which will distinguish three groups of patients:
- Those with physiological (age-related) annual decline: <2ml/min per 1.73 m²/year (non-progressors),
- Those with moderate annual decline ≥2 and <5 ml/min per 1.73 m²/year (moderate progressors)
- Those with rapid annual decline ≥5 ml/min per 1.73 m²/year (rapid progressors)
Measured: from day 1 of inclusion, up to 7 years
Secondary outcomes (6)
The evolution of vascular status
The evolution of vascular status will be assessed by blood pressure (SBP, DBP, DBP), central pressure and vascular stiffnes
Measured: from day 1 of inclusion, up to 7 years
Major cardiovascular event
Major cardiovascular event defined as cardiovascular death, myocardial infarction, hospitalization for heart failure, stroke (ischemic or hemorrhagic), or acute limb ischemia
Measured: from day 1 of inclusion, up to 7 years
microvascular event
-A microvascular event defined as the occurrence of complicated peripheral sensory neuropathy and/or the occurrence of proliferative retinopathy or metabolic blindness
Measured: from day 1 of inclusion, up to 7 years
Cognitive performance
Cognitive performance will be assessed by neuropsychological testing. A decline in cognitive performance will be defined as a decrease of at least 1.5 standard deviations on at least 1 neuropsychological test within a cognitive domain from the neuropsychological assessment performed at inclusion
Measured: from day 1 of inclusion, up to 7 years
The onset of dementia defined as a cognitive disorder
- The onset of dementia defined as a cognitive disorder as evidenced by the neuropsychological assessment performed at the end of the study resulting in a loss of functional autonomy in activities of daily living as measured by a loss of at least one point on the ADL scale (DSMV).deviations on at least 1 neuropsychological test within a cognitive domain from the neuropsychological assessment performed at inclusion
Measured: from day 1 of inclusion, up to 7 years
The occurrence of severe liver damage
The occurrence of severe liver damage will be defined by :
fibrosis, cirrhosis, hepatocarcinoma, or death of hepatic origin
Measured: from day 1 of inclusion, up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start3 May 2022 (estimated)
- Primary completion3 May 2032 (estimated)
- Study completion3 May 2032 (estimated)
Why it stopped: No inclusion within 2 years of approval by CPP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier Universitaire, Amiens, Biobanque de Picardie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307172
- Sponsor's protocol ID
- C21-13
- Other IDs
- 2021-A02192-39
- Acronym
- PRECIMETAB
- Status last verified
- Dec 2021
- First submitted
- 23 Mar 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Approach to Unravel the Risk Factors for Renal, Cardiovascular, Ophthalmologic, Neurologic and Hepatic Complications of Metabolic Disorders
- ClinicalTrials.gov ID
- NCT05307172
- Acronym / sponsor ID
- PRECIMETAB / C21-13
- Conditions
- Chronic Kidney Diseases, Diabetes, Obesity
- Keywords
- Chronic Kidney Diseases, Diabetes, Precision Medicine, Biomarkers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No inclusion within 2 years of approval by CPP
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Centre Hospitalier Universitaire, Amiens, Biobanque de Picardie
- Study start
- 3 May 2022 (estimated)
- Primary completion
- 3 May 2032 (estimated)
- Study completion
- 3 May 2032 (estimated)
- First posted
- 1 Apr 2022 (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.
There is currently no way to predict the progression of chronic kidney disease in patients with metabolic disease(s). Furthermore, the mechanisms responsible for the development and/or progression of complications remain largely unknown.
In order to identify the predictive factors and/or mechanisms involved in the different complications of these diseases, we propose an approach coupling :
- a classical phenotypic characterization (clinical, biological, imaging) of the patients
- high-throughput screening of the genome, transcriptome, metabolome, proteome, and immunophenotyping.
According to our hypothesis, this approach should allow :
- Early detection of complications
- Classification of patients in homogeneous groups of patients with identical evolution
- Identification of the molecular mechanisms involved.
Detailed description
Eligible patients will be detected during one of their consultations at the precision medicine center of the Amiens-Picardy University Hospital. They will be informed of the proposed research pathway during a care consultation. After a period of reflection, patients who accept this pathway will be included and a written consent form will be collected.
The inclusion visit will be scheduled at the precision medicine center of the Amiens-Picardy University Hospital and will take place during a day hospital (HDJ) which is part of a routine care pathway (neurological, cardiovascular, hepatic and renal primary prevention). At the time of inclusion, the informed consent will be signed by the investigator as well as by the patient The collection of data obtained during the patient's routine care will be performed by a physician from the Precision Medicine Center and a clinical research nurse and will be recorded in the patient's medical record.
Biological samples for the research (additional blood volume, urine) will be taken in conjunction with those for the routine check-up.
A hair strand of approximately 100 hairs (approx. 2 mm diameter) will be collected at the inclusion visit. This sample will be optional and will be subject to a specific authorization from the patient on the consent form.
Biological samples intended for research will be sent by the department's staff to the Biobank of Picardie (CHU Amiens-Picardie) for processing and storage.
The follow-up of the patient will be done strictly within the framework of his care adapted to his pathology. No visits will be made specifically for research purposes. The schedule of follow-up visits for the study corresponds to the visits usually scheduled as part of patient care: at 1 year after the inclusion visit (A1), at 4 years (A4) and at 7 years (A7).
In summary: One year after the inclusion visit, the patient will have a clinical and biological evaluation including a measurement of renal function to determine the rate of decline of glomerular filtration rate in order to classify the patient as a non-progressor, a moderate-progressor, or a rapid-progressor (see primary endpoints). The rate of decline of GFR will be correlated with clinical, biological, genetic and environmental data collected at patient inclusion, by means of dedicated questionnaires, biological results collected and analyses performed on research samples taken during the patient inclusion visit. The prognostic power of the classic clinical and biological criteria and of the new biomarkers discovered during the study to predict the patient's all-cause evolutionary profile will be evaluated́ by hazard ratio and 95% confidence interval. This reassessment will then be repeated at each visit until the end of the study.
Follow-up visits will be conducted in the same manner as the inclusion visit. The collection of data obtained during the routine care follow-up will be performed by a Precision Medicine Center physician and a clinical research nurse and will be recorded in the patient's medical record.
Additional biological samples (additional volume of blood, urine) will be taken during the care samples to meet the research objectives.
The occurrence of a pregnancy during the follow-up period will not constitute an exclusion criterion. The patient will be able to continue her participation in the study.
Failure to complete one of the follow-up visits will not be considered an early exit from the research. The patient will be scheduled for the next protocol visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, suffering from obesity and/or diabetes and presenting signs of renal parenchymal suffering, referred to the Amiens-Picardie University Hospital for monitoring of the renal function and screening in primary prevention of associated neurological, hepatic and cardiovascular comorbidities.
Key inclusion criteria (6 listed)
- Adult persons, male or female, age ≥ 18 and ≤ 65 years
- Persons able to understand the information provided and to object to it (at the discretion of the investigator)
- Patient affiliated to a social security system.
- Patient willing to sign an informed consent form
- Patient with the following metabolic profile Diabetic (of any type) treated or not (diabetes will be defined by a fasting blood glucose > 7mM or a HbA1c > 6.5% or by the use of an antidiabetic treatment) AND/OR Obese patient (BMI > 30 kg/m2) treated or not
Key exclusion criteria (8 listed)
- Patient deprived of liberty
- Person subject to a legal protection measure (guardianship, curatorship or safeguard of justice)
- Patient refusing to participate in the study
- Pregnant, parturient or nursing woman
- Patient in emergency situation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance
Time frame: from day 1 of inclusion, up to 7 years
The rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance, which will distinguish three groups of patients: * Those with physiological (age-related) annual decline: <2ml/min per 1.73 m²/year (non-progressors), * Those with moderate annual decline ≥2 and <5 ml/min per 1.73 m²/year (moderate progressors) * Those with rapid annual decline ≥5 ml/min per 1.73 m²/year (rapid progressors)
6 secondary outcomes
The evolution of vascular status
Time frame: from day 1 of inclusion, up to 7 years
Major cardiovascular event
Time frame: from day 1 of inclusion, up to 7 years
microvascular event
Time frame: from day 1 of inclusion, up to 7 years
Cognitive performance
Time frame: from day 1 of inclusion, up to 7 years
The onset of dementia defined as a cognitive disorder
Time frame: from day 1 of inclusion, up to 7 years
The occurrence of severe liver damage
Time frame: from day 1 of inclusion, up to 7 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Diabetes, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
the rate of annual decline in glomerular filtration rate (GFR year n+1 - GFR year n) measured by iohexol clearance (time frame: from day 1 of inclusion, up to 7 years). 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 16 May 2025.