CKD - Chronic Kidney DiseaseCLIFFNCT07676526
Association Between Chronic Kidney Disease Stage and Circulating FGF23 Cleavage Intensity in Patients With Chronic Kidney Disease
A study testing Blood sampling and biomarker assessment in people with CKD - Chronic Kidney Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This cross-sectional proof-of-concept study aims to investigate the relationship between chronic kidney disease (CKD) severity and circulating FGF23 (fibroblast growth factor 23) cleavage intensity estimated by the iFGF23/cFGF23 ratio. Read more about this study
- Who is it for?
- Ages 55 to 75 years, men only
- Conditions the study is for
- CKD - Chronic Kidney Disease
- What is being tested?
- Blood sampling and biomarker assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRC stage 3a-5 based on the most recent GFR measurement
- Patient enrolled in or eligible for a social security program
- Patients who have received informed consent regarding the study and have given their verbal consent to participate
Who cannot join
- Active cancer or a history of cancer in remission for less than 5 years, or a history of cancer in remission for more than 5 years with specific oncological treatment still ongoing.
- Participation in another study related to treatments for the disease
- Patients under legal guardianship (legal guardianship or conservatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Saint-Etienne
Saint-Etienne, 42055
Christophe MARIAT, PHD, (0)477828739 ext. +33, christophe.mariat@chu-st-etienne.fr
About this study
This cross-sectional proof-of-concept study aims to investigate the relationship between chronic kidney disease (CKD) severity and circulating FGF23 (fibroblast growth factor 23) cleavage intensity estimated by the iFGF23/cFGF23 ratio. Eighty male patients aged 55-75 years with CKD stages 3a to 5 will be included (20 per stage). Blood samples obtained during routine nephrology care will be supplemented by two additional tubes to measure iFGF23, cFGF23, hepcidin, erythropoietin, 1,25-vitamin D and TRAP5b. The primary endpoint is the iFGF23/cFGF23 ratio. Secondary analyses will evaluate the associations between FGF23 forms and renal, hematological, iron metabolism and mineral bone parameters. This study will provide the first human data on FGF23 cleavage alterations across CKD stages and may identify novel biomarkers for anemia and cardiovascular complications.
- Conditions
- CKD - Chronic Kidney Disease
- Being tested
- Blood sampling and biomarker assessment
- Keywords
- CKD, FGF23, iFGF23/cFGF23 ratio, iron metabolism, anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and biomarker assessmentOther
Single study visit during routine nephrology follow-up. Routine blood analyses are performed as standard care. Two additional tubes (maximum 10 mL) are collected:
- EDTA plasma tube for measurements of intact FGF23 (iFGF23), C-terminal FGF23 (cFGF23), and hepcidin.
- Serum tube for measurements of erythropoietin (EPO), 1,25-dihydroxyvitamin D, and TRAP5b.
Clinical and laboratory data collected include renal function parameters (eGFR, creatinine, urea, albuminuria), hematologic and iron metabolism markers (hemoglobin, ferritin, transferrin saturation, CRP), and bone-mineral metabolism markers (calcium, phosphate, PTH, vitamin D, bone alkaline phosphatase).
| Study group | Role | What they receive |
|---|---|---|
| Patients CKD 3a | Active comparator | Patients with stage 3a kidney disease during a nephrology consultation with an investigator (inclusion visit). Receives: Other: Blood sampling and biomarker assessment |
| Patients CKD 3b | Active comparator | Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit). Receives: Other: Blood sampling and biomarker assessment |
| Patients CKD 4 | Active comparator | Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit). Receives: Other: Blood sampling and biomarker assessment |
| Patients CKD 5 | Active comparator | Patients with stage 5 kidney disease during a nephrology consultation with an investigator (inclusion visit). Receives: Other: Blood sampling and biomarker assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients.
The intensity of FGF23 cleavage will be estimated using the iFGF23/cFGF23 ratio and compared across CKD stages 3a to 5.
Measured: At inclusion
Secondary outcomes (4)
Plasma concentrations of iFGF23 and cFGF23
Evaluation of changes in circulating intact FGF23 and C-terminal FGF23 concentrations according to CKD stage.
Measured: At inclusion
Association between FGF23 cleavage intensity and anemia-related parameters
Assessment of associations between iFGF23/cFGF23 ratio and hemoglobin, ferritin, transferrin saturation, CRP, hepcidin and erythropoietin independently of CKD stage.
Measured: At inclusion
Association between FGF23 concentrations and renal parameters
Assessment of associations between iFGF23 and cFGF23 concentrations and eGFR, creatinine and albuminuria using correlation and multivariable analyses.
Measured: At inclusion
Association between FGF23 concentrations and mineral-bone metabolism markers
Assessment of associations between iFGF23 and cFGF23 concentrations and phosphate, calcium, PTH, vitamin D, bone alkaline phosphatase and TRAP5b.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD - Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a descriptive, cross-sectional study conducted during a single visit, involving 80 patients with CKD at different stages of the disease: 3a, 3b, 4, and 5, with 20 patients per stage (4 groups).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MARIAT, PHD, Principal investigator, CHUSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676526
- Sponsor's protocol ID
- 25CH338
- Other IDs
- ANSM
- Acronym
- CLIFF
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Chronic Kidney Disease Stage and Circulating FGF23 Cleavage Intensity in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07676526
- Acronym / sponsor ID
- CLIFF / 25CH338
- Conditions
- CKD - Chronic Kidney Disease
- Keywords
- CKD, FGF23, iFGF23/cFGF23 ratio, iron metabolism, anemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Jun 2026 (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 cross-sectional proof-of-concept study aims to investigate the relationship between chronic kidney disease (CKD) severity and circulating FGF23 (fibroblast growth factor 23) cleavage intensity estimated by the iFGF23/cFGF23 ratio. Eighty male patients aged 55-75 years with CKD stages 3a to 5 will be included (20 per stage). Blood samples obtained during routine nephrology care will be supplemented by two additional tubes to measure iFGF23, cFGF23, hepcidin, erythropoietin, 1,25-vitamin D and TRAP5b. The primary endpoint is the iFGF23/cFGF23 ratio. Secondary analyses will evaluate the associations between FGF23 forms and renal, hematological, iron metabolism and mineral bone parameters. This study will provide the first human data on FGF23 cleavage alterations across CKD stages and may identify novel biomarkers for anemia and cardiovascular complications.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a descriptive, cross-sectional study conducted during a single visit, involving 80 patients with CKD at different stages of the disease: 3a, 3b, 4, and 5, with 20 patients per stage (4 groups).
| Arm | Type | Receives |
|---|---|---|
| Patients CKD 3a | Active comparator | Other: Blood sampling and biomarker assessmentPatients with stage 3a kidney disease during a nephrology consultation with an investigator (inclusion visit). |
| Patients CKD 3b | Active comparator | Other: Blood sampling and biomarker assessmentPatients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit). |
| Patients CKD 4 | Active comparator | Other: Blood sampling and biomarker assessmentPatients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit). |
| Patients CKD 5 | Active comparator | Other: Blood sampling and biomarker assessmentPatients with stage 5 kidney disease during a nephrology consultation with an investigator (inclusion visit). |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MRC stage 3a-5 based on the most recent GFR measurement
- Patient enrolled in or eligible for a social security program
- Patients who have received informed consent regarding the study and have given their verbal consent to participate
Key exclusion criteria (3 listed)
- Active cancer or a history of cancer in remission for less than 5 years, or a history of cancer in remission for more than 5 years with specific oncological treatment still ongoing.
- Participation in another study related to treatments for the disease
- Patients under legal guardianship (legal guardianship or conservatorship)
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 sampling and biomarker assessmentSingle study visit during routine nephrology follow-up. Routine blood analyses are performed as standard care. Two additional tubes (maximum 10 mL) are collected: * EDTA plasma tube for measurements of intact FGF23 (iFGF23), C-terminal FGF23 (cFGF23), and hepcidin. * Serum tube for measurements of erythropoietin (EPO), 1,25-dihydroxyvitamin D, and TRAP5b. Clinical and laboratory data collected include renal function parameters (eGFR, creatinine, urea, albuminuria), hematologic and iron metabolism markers (hemoglobin, ferritin, transferrin saturation, CRP), and bone-mineral metabolism markers (calcium, phosphate, PTH, vitamin D, bone alkaline phosphatase). | Other | Patients CKD 3a, Patients CKD 3b, Patients CKD 4, Patients CKD 5 |
Primary outcome
Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients.
Time frame: At inclusion
The intensity of FGF23 cleavage will be estimated using the iFGF23/cFGF23 ratio and compared across CKD stages 3a to 5.
4 secondary outcomes
Plasma concentrations of iFGF23 and cFGF23
Time frame: At inclusion
Association between FGF23 cleavage intensity and anemia-related parameters
Time frame: At inclusion
Association between FGF23 concentrations and renal parameters
Time frame: At inclusion
Association between FGF23 concentrations and mineral-bone metabolism markers
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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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.
Christophe MARIAT, PHD principal investigator
CHUSE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and biomarker assessment in people with CKD - Chronic Kidney Disease, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe MARIAT, PHD ((0)477828739 ext. +33, christophe.mariat@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients. (time frame: At inclusion). 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 31 Jul 2026.