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 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

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

Treatments tested in this trial

  • Blood sampling and biomarker assessment

Treatment groups

80 Participants
are divided into 4 treatment groups