CKD - Chronic Kidney Disease
Conditions
Keywords
CKD, FGF23, iFGF23/cFGF23 ratio, iron metabolism, anemia
Brief 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. 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.
Interventions
OTHERBlood sampling and biomarker assessment
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).
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
MALE
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients. | At inclusion | The intensity of FGF23 cleavage will be estimated using the iFGF23/cFGF23 ratio and compared across CKD stages 3a to 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of iFGF23 and cFGF23 | At inclusion | Evaluation of changes in circulating intact FGF23 and C-terminal FGF23 concentrations according to CKD stage. |
| Association between FGF23 cleavage intensity and anemia-related parameters | At inclusion | Assessment of associations between iFGF23/cFGF23 ratio and hemoglobin, ferritin, transferrin saturation, CRP, hepcidin and erythropoietin independently of CKD stage. |
| Association between FGF23 concentrations and renal parameters | At inclusion | Assessment of associations between iFGF23 and cFGF23 concentrations and eGFR, creatinine and albuminuria using correlation and multivariable analyses. |
| Association between FGF23 concentrations and mineral-bone metabolism markers | At inclusion | Assessment of associations between iFGF23 and cFGF23 concentrations and phosphate, calcium, PTH, vitamin D, bone alkaline phosphatase and TRAP5b. |
Countries
France
Contacts
CONTACTChristophe MARIAT, PHD
CONTACTClara PFENNINGER, CDP
PRINCIPAL_INVESTIGATORChristophe MARIAT, PHD
CHUSE
Outcome results
None listed