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CompletedNCT04393428COVID-AKIUpdated Jul 29, 2020

Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)

An observational study in COVID-19, Renal Replacement Therapy and Acute Kidney Injury, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-07-29.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 100 Years
Sex
All
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Study summary

Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.

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Conditions studied

  • COVID-19
  • Renal Replacement Therapy
  • Acute Kidney Injury

Keywords

  • Acute Kidney Injury
  • SARS-CoV-2
  • Renal Replacement Therapy
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 100 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 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 to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COVID-19 patients admitted to the Montpellier University Hospital with at least one rine sample drawn

Inclusion criteria

  • Age ≥ 18 years
  • COVID-19 confirmed by positive SARS-CoV-2 PCR
  • at least one urine sample

Exclusion criteria

Exclusion criteria:

  • Persons under protection
  • Paritcipation rejections
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • COVID-19 patients with urinary samples

    COVID-19 patients with urinary samples

    Other: [TIMP-2]*[IGFBP-7]

Interventions

  • Other[TIMP-2]*[IGFBP-7]

    \[TIMP-2\]\*\[IGFBP-7\] mesurement in urine sample relicates of COVID-19 patients admitted to the Montpellier University Hospital

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What researchers measure

Primary outcomes

  1. Sensibility and specificity of urinary

    Sensibility and specificity of urinary \[TIMP-2\]\*\[IGFBP-7\] \> 0,3 to predict AKI (KDIGO stage ≥ 1) in SARS-CoV-2 patients at day-7 after measurement

    Time frame: Occurence of AKI 7 days after urinary biomarkers measurement

Secondary outcomes

  1. Sensibility and specificity of urinary

    Sensibility and specificity of urinary \[TIMP-2\]\*\[IGFBP-7\] \> 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKI

    Time frame: Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement

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Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
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References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2020, 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
NCT04393428
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 19, 2020
Start date
Mar 1, 2020
Primary completion
Jun 1, 2020
Completion
Jun 30, 2020
Last update
Jul 29, 2020

Study contacts

Romaric Larcher, MD, PharmD, MSc
principal investigator · UH Montpellier

Oversight

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

Not currently enrolling

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

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