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NCT Number: NCT07676526

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

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.

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Key information

Conditions

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

Age range

55 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients.

    Time frame: At inclusion

    The intensity of FGF23 cleavage will be estimated using the iFGF23/cFGF23 ratio and compared across CKD stages 3a to 5.

Secondary outcomes

  1. Plasma concentrations of iFGF23 and cFGF23

    Time frame: At inclusion

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

  2. Association between FGF23 cleavage intensity and anemia-related parameters

    Time frame: At inclusion

    Assessment of associations between iFGF23/cFGF23 ratio and hemoglobin, ferritin, transferrin saturation, CRP, hepcidin and erythropoietin independently of CKD stage.

  3. Association between FGF23 concentrations and renal parameters

    Time frame: At inclusion

    Assessment of associations between iFGF23 and cFGF23 concentrations and eGFR, creatinine and albuminuria using correlation and multivariable analyses.

  4. Association between FGF23 concentrations and mineral-bone metabolism markers

    Time frame: At inclusion

    Assessment of associations between iFGF23 and cFGF23 concentrations and phosphate, calcium, PTH, vitamin D, bone alkaline phosphatase and TRAP5b.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe MARIAT, PHD

CONTACT

[email protected]

(0)477828739 ext. +33

Clara PFENNINGER, CDP

CONTACT

[email protected]

(0)477120287 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: CLIFF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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