Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

24. juni 2026 opdateret af: Centre Hospitalier Universitaire de Saint Etienne
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Patients CKD 3a
Patients with stage 3a kidney disease during a nephrology consultation with an investigator (inclusion visit).
Andet: 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 metabolism markers (hemoglobin, ferritin, transferrin saturation, CRP), and bone-mineral metabolism markers (calcium, phosphate, PTH, vitamin D, bone alkaline phosphatase).
Aktiv komparator: Patients CKD 3b
Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit).
Andet: 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 metabolism markers (hemoglobin, ferritin, transferrin saturation, CRP), and bone-mineral metabolism markers (calcium, phosphate, PTH, vitamin D, bone alkaline phosphatase).
Aktiv komparator: Patients CKD 4
Patients with stage 3b kidney disease during a nephrology consultation with an investigator (inclusion visit).
Andet: 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 metabolism markers (hemoglobin, ferritin, transferrin saturation, CRP), and bone-mineral metabolism markers (calcium, phosphate, PTH, vitamin D, bone alkaline phosphatase).
Aktiv komparator: Patients CKD 5
Patients with stage 5 kidney disease during a nephrology consultation with an investigator (inclusion visit).
Andet: 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 metabolism markers (hemoglobin, ferritin, transferrin saturation, CRP), and bone-mineral metabolism markers (calcium, phosphate, PTH, vitamin D, bone alkaline phosphatase).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the association between CKD stages and the intensity of circulating FGF23 cleavage in CKD patients.
Tidsramme: At inclusion
The intensity of FGF23 cleavage will be estimated using the iFGF23/cFGF23 ratio and compared across CKD stages 3a to 5.
At inclusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma concentrations of iFGF23 and cFGF23
Tidsramme: At inclusion
Evaluation of changes in circulating intact FGF23 and C-terminal FGF23 concentrations according to CKD stage.
At inclusion
Association between FGF23 cleavage intensity and anemia-related parameters
Tidsramme: At inclusion
Assessment of associations between iFGF23/cFGF23 ratio and hemoglobin, ferritin, transferrin saturation, CRP, hepcidin and erythropoietin independently of CKD stage.
At inclusion
Association between FGF23 concentrations and renal parameters
Tidsramme: At inclusion
Assessment of associations between iFGF23 and cFGF23 concentrations and eGFR, creatinine and albuminuria using correlation and multivariable analyses.
At inclusion
Association between FGF23 concentrations and mineral-bone metabolism markers
Tidsramme: At inclusion
Assessment of associations between iFGF23 and cFGF23 concentrations and phosphate, calcium, PTH, vitamin D, bone alkaline phosphatase and TRAP5b.
At inclusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: Christophe MARIAT, PHD, CHUSE

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25CH338
  • ANSM (Anden identifikator: 2017-A03433-50)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med CKD - ​​Kronisk nyresygdom

  • Shanghai Changzheng Hospital
    Rekruttering
    Kardiovaskulær-Kidney-metabolsk syndrom i Shanghai Zicicitizens
    Forhøjet blodtryk | Diabetes | Skjoldbruskkirtelsygdomme | Metabolisk syndrom | Dyslipidæmi | Knoglemetabolismeforstyrrelse | Kronisk nyresygdom (CKD) | Fedme og overvægt | Hjerte-kar-sygdomme (CVD) | Kardiovaskulær-Kidney-metabolsk syndrom
    Kina

Kliniske forsøg med Blood sampling and biomarker assessment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Nigeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner