Acute Kidney InjuryNCT04693962
FGF23 as a Marker of Acute Kidney Injury
An observational study of Acute Kidney Injury and Kidney Ischemia, run by University of Chile at 1 site in Chile.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Kidney Ischemia
- What is being tested?
- Plasmatic Fibroblast Growth Factor-23 by means of ELISA
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 1 Apr 2017to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with a diagnose that requires any of three surgerys: Partial Nephrectomy, Hemicolectomy, Nephrolithotomy
Who may be able to join
- 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.
Who cannot join
- History of chronic kidney disease
- Anemia
- Alterations in the parathormone or vitamin D axis
- Pregnant women
- Subjects with concomitant use of nephrotoxic drugs.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinic Universidad de Chile
Santiago
Nicolas J Valls, MD, +56933741332, nvallsj@hotmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Acute Kidney Injury, Kidney Ischemia
- Being tested
- Plasmatic Fibroblast Growth Factor-23 by means of ELISA
- Keywords
- Acute kidney injury, Creatinine, Fibroblast Growth Factor-23
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmatic Fibroblast Growth Factor-23 by means of ELISADiagnostic test
Plasma levels of FGF-23 will be measured by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Partial Nephrectomy (PN) | Patients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping. Receives: 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. Receives: 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 Receives: Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Patients that develop postoperative acute kidney injury
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Apr 2017
- Primary completion30 May 2020
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Valls Jimenez, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693962
- Sponsor's protocol ID
- OAIC 868/17
- Status last verified
- Dec 2020
- First submitted
- 30 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroblast Growth Factor-23 as a Marker of Acute Kidney Injury After Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT04693962
- Acronym / sponsor ID
- OAIC 868/17
- Conditions
- Acute Kidney Injury, Kidney Ischemia
- Keywords
- Acute kidney injury, Creatinine, Fibroblast Growth Factor-23
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Partial Nephrectomy (PN) | – | Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISAPatients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping. |
| Hemicolectomy (HC) | – | Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISAPatients who will undergo HC, as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC. |
| Nephrolithotomy (NL) | – | Diagnostic Test: Plasmatic Fibroblast Growth Factor-23 by means of ELISAPatients who undergo NL as non-renal ischemia surgery controls but with kidney physical injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnose that requires any of three surgerys: Partial Nephrectomy, Hemicolectomy, Nephrolithotomy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- History of chronic kidney disease
- Anemia
- Alterations in the parathormone or vitamin D axis
- Pregnant women
- Subjects with concomitant use of nephrotoxic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmatic Fibroblast Growth Factor-23 by means of ELISAPlasma levels of FGF-23 will be measured by ELISA | Diagnostic test | Hemicolectomy (HC), Nephrolithotomy (NL), Partial Nephrectomy (PN) |
Primary outcome
Acute Kidney Injury
Time frame: 72 hours
Patients that develop postoperative acute kidney injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Kidney Ischemia, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.