Association Between Chronic Kidney Disease Stage and Circulating FGF23 Cleavage Intensity in Patients With Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age55-75
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Blood sampling and biomarker assessment

    Other intervention

    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).

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Patients CKD 3aActive comparator 1 intervention
Group B: Patients CKD 3bActive comparator 1 intervention
Group C: Patients CKD 4Active comparator 1 intervention
Group D: Patients CKD 5Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At inclusion

Secondary outcomes

1

Plasma concentrations of iFGF23 and cFGF23

Evaluation of changes in circulating intact FGF23 and C-terminal FGF23 concentrations according to CKD stage.

Time frame
At inclusion
2

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.

Time frame
At inclusion
3

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.

Time frame
At inclusion
4

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.

Time frame
At inclusion

Other outcomes

Sponsors and contacts

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