Renal FunctionFREAGENCT02288663
Renal Function Assessment in the Elderly Using Plasma Creatinine Assay and Lean Body Mass Measurement
A study testing measurement of morphological parameters, a blood sample and albumin or blood in urine in people with Renal Function, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The reference technique to measure GFR (clearance of a glomerular agent) is not commonly used. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Function
- What is being tested?
- measurement of morphological parameters, a blood sample and albumin or blood in urine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2014to 2 Nov 2022
- Phase
- Interventional
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age of 75 years of more
- origin from Western Europe or North Africa
- covered by social health insurance
- general health condition allowing transportation and ambulatory procedures during one day
Who cannot join
- ascitis, oedema or third compartment
- fast change in body weight (more than 5% in less than one week)
- eGFR < 30 mL/min/1.73 m² (using MDRD formula)
- legal concerns: prisoners, guardianship, lack of health insurance, failure to consent
- intake of drugs that interfere with creatinine tubular secretion
- cimetidine
Show all 16Show fewer
- trimethoprim
- intake of drugs that interfere with creatinine assay
- calcium dobesilate
- hydroxocobalamin
- N-ethylglycine
- phenindione
- lidocaine
- inability to lie during 10 minutes without moving
- patients who are bedridden, hemiplegic or highly dependent on others
- any health condition that, in the investigator's opinion, could rapidly (< 1 week) vary the extracellular volume or GFR (these is voluntarily left open to the investigator because it is hardly possible to make an exhaustive list here)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Fabrice HUBELE, MD, 3 88 12 75 47 ext. 0033, fabrice.hubele@chru-strasbourg.fr
About this study
Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The reference technique to measure GFR (clearance of a glomerular agent) is not commonly used. Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at predicting the endogenous creatinine production by morphological parameters (age, body weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is quite commonly encountered (frequently linked to Alzheimer disease). This is probably the main reason why the aforementioned formulae are not valid in this population: for a given renal function, a lower muscular mass induces a lower creatinine production and, henceforth, a lower SCr value, which gives an overestimation of eGFR.
Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance Spectroscopy (BIS) can also be used.
Read more
Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and LBM estimation from DXA. Proof of concept has already been made by others but until now, no specific formula for the elderly has been devised and properly validated.
Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM (estimated from DXA) in the elderly. This formula will be elaborated from a first series of 100 patients and validated on a second series of 100 other patients.
- Conditions
- Renal Function
- Being tested
- measurement of morphological parameters, a blood sample, albumin or blood in urine, Dual X-ray absorptiometry (DXA), Bioelectric Impedance Spectroscopy (BIS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of morphological parametersOther
measurement of morphological parameters : thigh perimeter, leg perimeter, arm perimeter.
a blood sampleBiological
One single blood sample to assay SCr (enzymatic), BUN (blood urea nitrogen), cystatin C, CRP, Na, K, Cl, albuminemia.
albumin or blood in urineBiological
dipstick analysis for albumin or blood in urine
Dual X-ray absorptiometry (DXA)Device
measurement of lean body mass by whole-body DXA
Bioelectric Impedance Spectroscopy (BIS)Device
measurement of lean body mass by BIS
51Cr-EDTA plasma clearanceBiological
measurement of 51Cr-EDTA plasma clearance to determine GFR
| Study group | Role | What they receive |
|---|---|---|
| Freage group | Other | only one group in this trial. All the participants will follow all the listed interventions. Receives: Other: measurement of morphological parameters; Biological: a blood sample; Biological: albumin or blood in urine; Device: Dual X-ray absorptiometry (DXA); Device: Bioelectric Impedance Spectroscopy (BIS); Biological: 51Cr-EDTA plasma clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCr and LBM estimated from DXA
The formula that will be designed (using SCr and LBM estimated from DXA) from the first 100 patient data, will match measured GFR (as given by 51Cr-EDTA clearance) with less than 10 mL/min/1.73 m² absolute error in more than 90% of the other 100 patients.
Measured: Each participant is followed for one day.
Secondary outcomes (7)
SCr and lean body mass ( by DXA)
Detection of patient with impaired renal function by measuring SCr and lean body mass by DXA better than with existing formulas.
Measured: Each participant is followed for one day.
SCr and lean body mass (by BIS)
A formula using SCr and measurement of lean body mass by bioelectric impedance spectrometry that will match measured GFR (as given by 51Cr-EDTA clearance) with less than 10 mL/min/1.73 m² absolute error in more than 90% of the other 100 patients.
Measured: Each participant is followed for one day.
SCr and morphological parameters
A formula using SCr and measurement of morphological parameters (thigh perimeter, leg perimeter, arm perimeter) that will match measured GFR (as given by 51Cr-EDTA clearance) with less than 10 mL/min/1.73 m² absolute error in more than 90% of the other 10
Measured: Each participant is followed for one day.
Accuracy of new formulae
The new formulae outperform eGFR (Cockcroft and Gault, MDRD and CKD-EPI formulae) for the following criteria: better accuracy (smaller bias) according to Bland and Altman
Measured: Each participant is followed for one day.
Precision of new formulae
The new formulae outperform eGFR (Cockcroft and Gault, MDRD and CKD-EPI formulae) for the following criteria: better precision (smaller SD of difference) according to Bland and Altman.
Measured: Each participant is followed for one day.
Sensitivity of new formulae
The new formulae outperform eGFR (Cockcroft and Gault, MDRD and CKD-EPI formulae) for the following criteria: sensitivity to detect GFR < 60 mL/min/1.73 m²
Measured: Each participant is followed for one day.
Specificity of new formulae
The new formulae outperform eGFR (Cockcroft and Gault, MDRD and CKD-EPI formulae) for the following criteria: specificity to detect GFR < 60 mL/min/1.73 m²
Measured: Each participant is followed for one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study start3 Nov 2014
- Primary completion2 Nov 2022 (estimated)
- Study completion2 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288663
- Sponsor's protocol ID
- 5744
- Acronym
- FREAGE
- Status last verified
- Jun 2021
- First submitted
- 8 Jul 2014
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Function Assessment in the Elderly Using Plasma Creatinine Assay and Lean Body Mass Measurement
- ClinicalTrials.gov ID
- NCT02288663
- Acronym / sponsor ID
- FREAGE / 5744
- Conditions
- Renal Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 2 Nov 2022 (estimated)
- Study completion
- 2 Nov 2022 (estimated)
- First posted
- 11 Nov 2014 (estimated)
- 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.
Glomerular filtration rate (GFR) is the recommended parameter to assess renal function. The reference technique to measure GFR (clearance of a glomerular agent) is not commonly used. Instead, estimations (eGFR) are routinely taken from serum creatinine (SCr) with several published formulae: Cockcroft and Gault, MDRD, CKD-EPI. Basically, all these formulae aim at predicting the endogenous creatinine production by morphological parameters (age, body weight...) However, in the elderly, muscular mass is extremely variable and sarcopenia is quite commonly encountered (frequently linked to Alzheimer disease). This is probably the main reason why the aforementioned formulae are not valid in this population: for a given renal function, a lower muscular mass induces a lower creatinine production and, henceforth, a lower SCr value, which gives an overestimation of eGFR.
Muscular mass is closely linked to lean body mass (LBM), which can be properly assessed by whole-body dual X-ray absorptiometry (DXA). Alternatively, Bioelectric Impedance Spectroscopy (BIS) can also be used.
Investigators postulate that it is possible to estimate GFR in the elderly from both SCr and LBM estimation from DXA. Proof of concept has already been made by others but until now, no specific formula for the elderly has been devised and properly validated.
Investigators'aim is thus to propose a new formula to predict GFR from both SCr and LBM (estimated from DXA) in the elderly. This formula will be elaborated from a first series of 100 patients and validated on a second series of 100 other patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freage group | Other | Other: measurement of morphological parameters, Biological: a blood sample, Biological: albumin or blood in urine, Device: Dual X-ray absorptiometry (DXA), Device: Bioelectric Impedance Spectroscopy (BIS), Biological: 51Cr-EDTA plasma clearanceonly one group in this trial. All the participants will follow all the listed interventions. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age of 75 years of more
- origin from Western Europe or North Africa
- covered by social health insurance
- general health condition allowing transportation and ambulatory procedures during one day
Key exclusion criteria (16 listed)
- ascitis, oedema or third compartment
- fast change in body weight (more than 5% in less than one week)
- eGFR < 30 mL/min/1.73 m² (using MDRD formula)
- legal concerns: prisoners, guardianship, lack of health insurance, failure to consent
- intake of drugs that interfere with creatinine tubular secretion
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 |
|---|---|---|
| measurement of morphological parametersmeasurement of morphological parameters : thigh perimeter, leg perimeter, arm perimeter. | Other | Freage group |
| a blood sampleOne single blood sample to assay SCr (enzymatic), BUN (blood urea nitrogen), cystatin C, CRP, Na, K, Cl, albuminemia. | Biological | Freage group |
| albumin or blood in urinedipstick analysis for albumin or blood in urine | Biological | Freage group |
| Dual X-ray absorptiometry (DXA)measurement of lean body mass by whole-body DXA | Device | Freage group |
| Bioelectric Impedance Spectroscopy (BIS)measurement of lean body mass by BIS | Device | Freage group |
| 51Cr-EDTA plasma clearancemeasurement of 51Cr-EDTA plasma clearance to determine GFR | Biological | Freage group |
Primary outcome
SCr and LBM estimated from DXA
Time frame: Each participant is followed for one day.
The formula that will be designed (using SCr and LBM estimated from DXA) from the first 100 patient data, will match measured GFR (as given by 51Cr-EDTA clearance) with less than 10 mL/min/1.73 m² absolute error in more than 90% of the other 100 patients.
7 secondary outcomes
SCr and lean body mass ( by DXA)
Time frame: Each participant is followed for one day.
SCr and lean body mass (by BIS)
Time frame: Each participant is followed for one day.
SCr and morphological parameters
Time frame: Each participant is followed for one day.
Accuracy of new formulae
Time frame: Each participant is followed for one day.
Precision of new formulae
Time frame: Each participant is followed for one day.
Sensitivity of new formulae
Time frame: Each participant is followed for one day.
Specificity of new formulae
Time frame: Each participant is followed for one day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of morphological parameters, a blood sample and albumin or blood in urine in people with Renal Function, run by University Hospital, Strasbourg, 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel DURAND, Professor (3 69 55 04 58 ext. 0033, durandem@club-internet.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCr and LBM estimated from DXA (time frame: Each participant is followed for one day.). 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 14 Jun 2021; AzTrials last refreshed its copy on 3 Nov 2026.