Association Between Chronic Kidney Disease Stage and Circulating FGF23 Cleavage Intensity in Patients With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling and biomarker assessment.
- Who it may be relevant to
- Registry conditions: CKD - Chronic Kidney Disease. Basic parameters: 55 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Blood 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 metabol
Primary outcome measures
- Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients. [Time frame: At inclusion]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT07676526 · 25CH338 · ANSM