FGF23 as a Marker of Acute Kidney Injury

Fibroblast Growth Factor-23 as a Marker of Acute Kidney Injury After Partial Nephrectomy

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.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Injury; Kidney Ischemia
• Intervention / Treatment: Diagnostic test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Hospital Clinic Universidad de Chile
    • Contact: Nicolas J Valls, MD; Phone Number: +56933741332; Email: nvallsj@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnose that requires any of three surgerys: Partial Nephrectomy, Hemicolectomy, Nephrolithotomy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury	Patients that develop postoperative acute kidney injury	72 hours

Collaborators and Investigators

• Sponsor: University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 30, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Acute kidney injury; Creatinine; Fibroblast Growth Factor-23
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Ischemia; Wounds and Injuries; Acute Kidney Injury; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: OAIC 868/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No