CClinicalTrials.gg
Status unknownNCT04693962Updated Jan 5, 2021

FGF23 as a Marker of Acute Kidney Injury

An observational study in Acute Kidney Injury and Kidney Ischemia, sponsored by University of Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by University of Chile · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Acute Kidney Injury
  • Kidney Ischemia

Keywords

  • Acute kidney injury
  • Creatinine
  • Fibroblast Growth Factor-23
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 40 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • Diagnostic testPlasmatic Fibroblast Growth Factor-23 by means of ELISA

    Plasma levels of FGF-23 will be measured by ELISA

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What researchers measure

Primary outcomes

  1. Acute Kidney Injury

    Patients that develop postoperative acute kidney injury

    Time frame: 72 hours

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Study locations

1 of 1 sites recruiting
  • Hospital Clinic Universidad de Chile
    Santiago, Chile
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04693962
Lead sponsor
University of Chile
Responsible party
Nicolas Valls Jimenez (MD, MSc, University of Chile) — Principal investigator
First posted
Jan 5, 2021
Start date
Apr 1, 2017
Primary completion
May 30, 2020
Completion
Dec 1, 2021 (estimated)
Last update
Jan 5, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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