Hamburg Acute Renal Injury (HARIS) cohort
Official title: Hamburg Acute Kidney Injury Study
Run by Universitätsklinikum Hamburg-Eppendorf · NCT07338669 · Data updated 2026-11-12
This project will follow adults hospitalized with AKI and a group of similar hospitalized patients without AKI to test which clinical factors and blood or urine markers predict recovery and longer-term kidney and cardiovascular problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | September 16, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2030 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07338669 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) hospitalized at the University Medical Center Hamburg-Eppendorf who either meet KDIGO criteria for AKI or are hospitalized with acute illness but have not developed AKI, and who can provide informed consent, are ideal candidates.
✕Probably not a fit
People who are not hospitalized, are under 18, seek immediate experimental therapy, or require urgent interventional treatment are unlikely to receive direct clinical benefit from this observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
HARIS is a prospective observational cohort enrolling adults hospitalized with acute kidney injury and a parallel control group of hospitalized adults with acute illness who did not develop AKI. An IT-supported screening system flags eligible patients in real time, and participants receive standardized clinical assessments, serial lab testing, and repeated blood and urine biosample collection during hospitalization and at three months after discharge. Biospecimens are processed through a harmonized pipeline and stored in the Hamburg and European Renal Omics-Biobank (HERO) to enable biomarker and omics analyses. Annual structured follow-ups capture long-term outcomes including progression to chronic kidney disease, cardiovascular events, hospital readmissions, and mortality.
Why it matters
Potential benefit: If successful, the study could help doctors predict who is at high risk after AKI and guide more personalized follow-up and treatment using validated biomarkers.
How similar studies have gone: Other observational AKI cohorts and biomarker studies have identified promising markers and risk models, but translation into routine clinical practice has been limited and results have been mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * None
Where it's running
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Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Tobias B Huber, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Christian Schmidt-Lauber, MD
- Email: c.schmidt-lauber@uke.de
- Phone: +49 (0) 40 7410 53908
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.