ClinicalTrials.Veeva

Menu

FGF23 as a Marker of Acute Kidney Injury

U

University of Chile

Status

Unknown

Conditions

Acute Kidney Injury
Kidney Ischemia

Treatments

Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA

Study type

Observational

Funder types

Other

Identifiers

NCT04693962
OAIC 868/17

Details and patient eligibility

About

A partial nephrectomy (PN) preserves renal parenchyma with a proper oncology outcome. PN is performed during transitory ischemia to avoid massive bleeding during tumor resection. Nevertheless, the transitory ischemia might cause an acute kidney injury(AKI). AKI diagnose is based on the increase in plasma creatinine concentration and a decrease in urine output. However, both plasma creatinine concentration and diuresis are useful for the diagnose, but not in the detection of the risk patients. Therefore, there is considerable interest to find a biomarkers of kidney injury that allow clinicians to predict the development of AKI. Hence, we propose Fibroblastic Growth Factor-23 (FGF23) as a novel early biomarker to detect patients in risk to develop postoperative AKI after a PN.

We will conduct an observational and prospective study in three different groups of patients: PN gropup, patients who underwent PN with a transient and controlled renal ischemia injury using a renal artery clamping; Hemicolectomy (HC) group, patients as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC; and Nephrolithotomy (NL) group, patients who underwent NL, as a control of kidney surgery with physical injury.

In each patient, a time curve of plasmatic creatinine, blood urea nitrogen (BUN), and FGF23 were measure.

Our study aims to describe the role of FGF23 as an early biomarker of AKI after PN, where patients are exposed to a controlled ischemic injury.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiology physical status (ASA) I or II.
  • Normal preoperative plasma creatinine level
  • Baseline estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2.

Exclusion criteria

  • History of chronic kidney disease
  • Anemia
  • Alterations in the parathormone or vitamin D axis
  • Pregnant women
  • Subjects with concomitant use of nephrotoxic drugs.

Trial design

40 participants in 3 patient groups

Partial Nephrectomy (PN)
Description:
Patients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping.
Treatment:
Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA
Hemicolectomy (HC)
Description:
Patients who will undergo HC, as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC.
Treatment:
Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA
Nephrolithotomy (NL)
Description:
Patients who undergo NL as non-renal ischemia surgery controls but with kidney physical injury
Treatment:
Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems