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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2026-A00630-51 |
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This cross-sectional proof-of-concept study aims to investigate the relationship between chronic kidney disease (CKD) severity and circulating FGF23 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients CKD 3a | Active Comparator | Patients with stage 3a kidney disease during a nephrology consultation with an investigator (inclusion visit). |
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| Patients CKD 3b | Active Comparator | Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit). |
|
| Patients CKD 4 | Active Comparator | Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit). |
|
| Patients CKD 5 | Active Comparator | Patients with stage 5 kidney disease during a nephrology consultation with an investigator (inclusion visit). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling and biomarker assessment | Other | Single study visit during routine nephrology follow-up. Routine blood analyses are performed as standard care. Two additional tubes (maximum 10 mL) are collected:
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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of iFGF23 and cFGF23 | Evaluation of changes in circulating intact FGF23 and C-terminal FGF23 concentrations according to CKD stage. | At inclusion |
| Association between FGF23 cleavage intensity and anemia-related parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe MARIAT, PHD | Contact | (0)477828739 | +33 | christophe.mariat@chu-st-etienne.fr |
| Clara PFENNINGER, CDP | Contact | (0)477120287 | +33 | clara.pfenninger@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe MARIAT, PHD | CHUSE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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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).
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Assessment of associations between iFGF23/cFGF23 ratio and hemoglobin, ferritin, transferrin saturation, CRP, hepcidin and erythropoietin independently of CKD stage.
| 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. | 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. | At inclusion |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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