Acute Kidney InjuryNCT04353583
Acute Kidney Injury and Acute Kidney Disease in COVID-19
An observational study of Acute Kidney Injury and Corona Virus Infection, run by University of Giessen at 1 site in Germany.
Trial summary
Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Corona Virus Infection
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 21 Apr 2020to 1 Feb 2025
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with diagnosed COVID-19
Who may be able to join
- 1) Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria
Who cannot join
- Patients aged less than 18 years
- Patients with stage 4 chronic kidney disease (baseline estimated glomerular filtration rate <30 ml/min/1.73 m2)
- Patients receiving maintenance dialysis
- Recipients of solid-organ transplantation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Giessen and Marburg, Giessen
Giessen, Hesse, 35382
About this study
Official title: Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients With Coronavirus Disease 2019 (COVID-19)
Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.
Read the detailed description
Beginning in December 2019, a novel coronavirus, designated as severe acute respiratory distress coronavirus 2 (SARS-CoV-2), has caused an international outbreak of respiratory illness termed coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients show severe kidney abnormalities. Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.
- Conditions
- Acute Kidney Injury, Corona Virus Infection
- Medical subject headings
- Acute Kidney Injury, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Inpatients with COVID-19 requiring ICU care | |
| Non-ICU patients | Inpatients with COVID-19 not requiring ICU care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI
Serial assessment of serum creatinine and urine output
Measured: 30 days post-hospital admission
Cystatin C as indicator of mortality
All-cause mortality
Measured: 30 days post-hospital admission
Cystatin C as indicator of renal disease
AKI and acute kidney disease (AKD)
Measured: 30 days post-hospital admission
Cystatin C as indicator of respiratory illness
Ventilator-free days
Measured: 30 days post-hospital admission
Cystatin C as indicator of disease severity
Rate of intensive care unit admission
Measured: 30 days post-hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start21 Apr 2020
- Primary completion17 May 2022
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 900 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Seeger, MD, Study director, University Hospital Giessen and Marburg, Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353583
- Sponsor's protocol ID
- AZ 58/20
- Status last verified
- Mar 2025
- First submitted
- 6 Apr 2020
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.
PubMed 32204907
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients With Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04353583
- Acronym / sponsor ID
- AZ 58/20
- Conditions
- Acute Kidney Injury, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 20 Apr 2020 (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.
Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.
Detailed description
Beginning in December 2019, a novel coronavirus, designated as severe acute respiratory distress coronavirus 2 (SARS-CoV-2), has caused an international outbreak of respiratory illness termed coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients show severe kidney abnormalities. Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | –Inpatients with COVID-19 requiring ICU care |
| Non-ICU patients | – | –Inpatients with COVID-19 not requiring ICU care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with diagnosed COVID-19
Key inclusion criteria (1 listed)
- 1) Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria
Key exclusion criteria (4 listed)
- Patients aged less than 18 years
- Patients with stage 4 chronic kidney disease (baseline estimated glomerular filtration rate <30 ml/min/1.73 m2)
- Patients receiving maintenance dialysis
- Recipients of solid-organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of AKI
Time frame: 30 days post-hospital admission
Serial assessment of serum creatinine and urine output
Cystatin C as indicator of mortality
Time frame: 30 days post-hospital admission
All-cause mortality
Cystatin C as indicator of renal disease
Time frame: 30 days post-hospital admission
AKI and acute kidney disease (AKD)
Cystatin C as indicator of respiratory illness
Time frame: 30 days post-hospital admission
Ventilator-free days
Cystatin C as indicator of disease severity
Time frame: 30 days post-hospital admission
Rate of intensive care unit admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Results publication: PubMed 32204907Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Kidney Injury
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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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.
Werner Seeger, MD study director
University Hospital Giessen and Marburg, Giessen
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 Corona Virus Infection, run by University of Giessen at 1 site in Germany.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AKI (time frame: 30 days post-hospital admission). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353583, which also lists 1 linked publication.
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 6 Mar 2025.