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

NCT07676526 | Not Yet Recruiting

• 2 other identifiers: 25CH338ANSM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

CKD - Chronic Kidney Disease

Keywords

CKD; FGF23; iFGF23/cFGF23 ratio; iron metabolism; anemia

Outcome Measures

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.

  At inclusion

Secondary Outcomes (4)

• Plasma concentrations of iFGF23 and cFGF23

  At inclusion

• Association between FGF23 cleavage intensity and anemia-related parameters

  At inclusion

• Association between FGF23 concentrations and renal parameters

  At inclusion

• Association between FGF23 concentrations and mineral-bone metabolism markers

  At inclusion

Study Arms (4)

Patients CKD 3a

ACTIVE COMPARATOR

Patients with stage 3a kidney disease during a nephrology consultation with an investigator (inclusion visit).

Other: Blood sampling and biomarker assessment

Patients CKD 3b

ACTIVE COMPARATOR

Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit).

Other: Blood sampling and biomarker assessment

Patients CKD 4

ACTIVE COMPARATOR

Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit).

Other: Blood sampling and biomarker assessment

Patients CKD 5

ACTIVE COMPARATOR

Patients with stage 5 kidney disease during a nephrology consultation with an investigator (inclusion visit).

Other: Blood sampling and biomarker assessment

Interventions

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: * 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).

Patients CKD 3a; Patients CKD 3b; Patients CKD 4; Patients CKD 5

Eligibility Criteria

• Age: 55 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christophe MARIAT, PHD

  CHUSE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe MARIAT, PHD

CONTACT

(0)477828739; christophe.mariat@chu-st-etienne.fr

Clara PFENNINGER, CDP

CONTACT

(0)477120287; clara.pfenninger@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-06

Locations

FR (1)