Acute Kidney InjuryHAKISNCT07338669
Hamburg Acute Kidney Injury Study (HAKIS)
An observational study of Acute Kidney Injury and Acute Kidney Injury (AKI), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Injury (AKI)
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2025to Sep 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 individuals with acute kidney injury (AKI) or at risk for AKI will be identified during routine medical care and invited for study participation. Routine clinical identification of AKI includes an IT-based screening system.
Who may be able to join
- Hospitalized individuals with acute kidney injury (AKI), defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria or hospitalized individuals with acute illness who have not developed AKI (control group)
- Age ≥ 18 years at time of enrollment
- Written informed consent provided by the participant or, in participants lacking decision-making capacity, by a legal representative or healthcare proxy, where available. Participants lacking decision-making capacity without an available legal representative or healthcare proxy may be enrolled if participation is not contrary to their presumed wishes, in accordance with the ethics committee-approved consent procedure. Written informed consent is subsequently sought from the participant upon regaining decision-making capacity or from a legal representative, as applicable.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20249
Alexandre Klopp, MD, +49 (0) 40 7410 53908, a.klopp@uke.de
About this study
Official title: Hamburg Acute Kidney Injury Study
The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.
Read the detailed description
The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study that includes hospitalized adults (≥18 years) at the time of acute kidney injury (AKI). Potential participants are identified during hospital care, and a structured IT-supported clinical screening system helps detect AKI cases in real time. In parallel, a control group of hospitalized adults with acute illness who have not developed AKI is enrolled to enable comparative analyses of specific risk factors, pathophysiology, and outcomes. All participants undergo a standardized clinical assessment of kidney function, comorbidities, hemodynamic status, medication exposure, procedures, and laboratory parameters. The study includes serial collection of clinical data and biosamples (blood and urine) at study inclusion, during hospitalization, and at 3-month after discharge. All biospecimens are processed within a harmonized pipeline and stored in the Hamburg and European Renal Omics-Biobank (HERO). Beyond the identification of clinical determinants of AKI trajectories, the central objective of HAKIS is to identify biological pathways of sustained kidney injury and repair, improve risk stratification, evaluated prognostic biomarkers, and support the development of precision medicine approaches in post AKI care. Long-term outcomes including progressive chronic kidney disease, cardiovascular events, hospital readmissions, and mortality are collected through annual structured follow-ups. No experimental interventions are performed and all clinical management follows standard of care.
- Conditions
- Acute Kidney Injury, Acute Kidney Injury (AKI)
- Keywords
- Acute Kidney Injury, AKI, Prospective observational cohort study
- 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.
| Study group | Role | What they receive |
|---|---|---|
| AKI group | Group consists of adult hospitalized individuals, who meet the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria for acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice. | |
| Control group | Group consists of adult hospitalized individuals with an acute illness, who have not developed acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Function Recovery after AKI
Improvement of kidney function after acute kidney injury, defined by partial or complete return of the kidney function toward baseline values
Measured: assessed at discharge, 3-months after discharge, and annual follow-up
Persistent Kidney Function Decline
Sustained impairment of kidney function following acute kidney injury, characterized by incomplete recovery and persistently reduced kidney function over follow-up.
Measured: assessed at discharge, 3-months after discharge, and annual follow-up
Development or Progression of Chronic Kidney Disease
New onset or worsening of chronic kidney disease during follow-up, assessed based on changes in kidney function over time.
Measured: assessed at 3-months after discharge, and annual follow-up
End-stage kidney disease (ESKD)
Occurrence of ESKD, characterized by the initiation of maintenance kidney replacement therapy, kidney transplantation or a persistent eGFR < 15 ml/min/1.73m2
Measured: assessed at discharge, 3-months after discharge, and annual follow-up
Renal mortality
Death attributable to kidney-related causes as determined by medical record review.
Measured: assessed at discharge, 3-months after discharge, and annual follow-up
Cardiovascular Outcomes
cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke
Measured: assessed at discharge, 3-months after discharge, and annual follow-up
Secondary outcomes (5)
Incidence of vascular diseases
Occurrence of vascular disease, including coronary artery disease, peripheral artery disease, or cerebrovascular disease after AKI
Measured: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Dementia
New diagnosis of dementia occurring during follow-up after AKI
Measured: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Cancer
New diagnosis of malignant disease occurring during follow-up after AKI
Measured: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Infections
New diagnosis of infections occurring during follow-up after AKI
Measured: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of psychosomatic or Psychiatric Disorders
New diagnosis of psychosomatic or psychiatric disorders occurring during follow-up after AKI
Measured: assessed at discharge, 3 months after discharge, and annual follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start16 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2030 (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
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias B Huber, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338669
- Sponsor's protocol ID
- PV6037-4337-BO-ff HAKIS
- Acronym
- HAKIS
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hamburg Acute Kidney Injury Study
- ClinicalTrials.gov ID
- NCT07338669
- Acronym / sponsor ID
- HAKIS / PV6037-4337-BO-ff HAKIS
- Conditions
- Acute Kidney Injury, Acute Kidney Injury (AKI)
- Keywords
- Acute Kidney Injury, AKI, Prospective observational cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 14 Jan 2026 (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.
The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.
Detailed description
The Hamburg Acute Kidney Injury Study (HAKIS) is a prospective observational cohort study that includes hospitalized adults (≥18 years) at the time of acute kidney injury (AKI). Potential participants are identified during hospital care, and a structured IT-supported clinical screening system helps detect AKI cases in real time. In parallel, a control group of hospitalized adults with acute illness who have not developed AKI is enrolled to enable comparative analyses of specific risk factors, pathophysiology, and outcomes. All participants undergo a standardized clinical assessment of kidney function, comorbidities, hemodynamic status, medication exposure, procedures, and laboratory parameters. The study includes serial collection of clinical data and biosamples (blood and urine) at study inclusion, during hospitalization, and at 3-month after discharge. All biospecimens are processed within a harmonized pipeline and stored in the Hamburg and European Renal Omics-Biobank (HERO). Beyond the identification of clinical determinants of AKI trajectories, the central objective of HAKIS is to identify biological pathways of sustained kidney injury and repair, improve risk stratification, evaluated prognostic biomarkers, and support the development of precision medicine approaches in post AKI care. Long-term outcomes including progressive chronic kidney disease, cardiovascular events, hospital readmissions, and mortality are collected through annual structured follow-ups. No experimental interventions are performed and all clinical management follows standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI group | – | –Group consists of adult hospitalized individuals, who meet the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria for acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice. |
| Control group | – | –Group consists of adult hospitalized individuals with an acute illness, who have not developed acute kidney injury (AKI). Participants will be prospectively followed for clinical course, kidney function, biomarker analysis, and outcomes. No experimental interventions are performed. All care follows standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized individuals with acute kidney injury (AKI) or at risk for AKI will be identified during routine medical care and invited for study participation. Routine clinical identification of AKI includes an IT-based screening system.
Key inclusion criteria (3 listed)
- Hospitalized individuals with acute kidney injury (AKI), defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria or hospitalized individuals with acute illness who have not developed AKI (control group)
- Age ≥ 18 years at time of enrollment
- Written informed consent provided by the participant or, in participants lacking decision-making capacity, by a legal representative or healthcare proxy, where available. Participants lacking decision-making capacity without an available legal representative or healthcare proxy may be enrolled if participation is not contrary to their presumed wishes, in accordance with the ethics committee-approved consent procedure. Written informed consent is subsequently sought from the participant upon regaining decision-making capacity or from a legal representative, as applicable.
Key exclusion criteria (1 listed)
- None
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
Kidney Function Recovery after AKI
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
Improvement of kidney function after acute kidney injury, defined by partial or complete return of the kidney function toward baseline values
Persistent Kidney Function Decline
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
Sustained impairment of kidney function following acute kidney injury, characterized by incomplete recovery and persistently reduced kidney function over follow-up.
Development or Progression of Chronic Kidney Disease
Time frame: assessed at 3-months after discharge, and annual follow-up
New onset or worsening of chronic kidney disease during follow-up, assessed based on changes in kidney function over time.
End-stage kidney disease (ESKD)
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
Occurrence of ESKD, characterized by the initiation of maintenance kidney replacement therapy, kidney transplantation or a persistent eGFR < 15 ml/min/1.73m2
Renal mortality
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
Death attributable to kidney-related causes as determined by medical record review.
Cardiovascular Outcomes
Time frame: assessed at discharge, 3-months after discharge, and annual follow-up
cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke
5 secondary outcomes
Incidence of vascular diseases
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Dementia
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Cancer
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Infections
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of psychosomatic or Psychiatric Disorders
Time frame: assessed at discharge, 3 months after discharge, and annual follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
Tobias B Huber, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
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 Acute Kidney Injury (AKI), run by Universitätsklinikum Hamburg-Eppendorf 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Schmidt-Lauber, MD (+49 (0) 40 7410 53908, c.schmidt-lauber@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Function Recovery after AKI (time frame: assessed at discharge, 3-months after discharge, and annual follow-up). The study lists 6 primary outcomes in all. 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 1 Oct 2026.