Hamburg Acute Renal Injury Study (HARIS) (HARIS)

Hamburg Acute Renal Injury Study

The Hamburg Acute Renal Injury Study (HARIS) is a prospective observational cohort study aimed at investigating the mechanisms, risk factors, and clinical determinants of acute kidney injury (AKI) trajectories and consequences.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Acute Kidney Injury (AKI)

Detailed Description

The Hamburg Acute Renal Injury Study (HARIS) 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 HARIS 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Christian Schmidt-Lauber, MD; Phone Number: +49 (0) 40 7410 53908; Email: c.schmidt-lauber@uke.de
• Study Contact Backup: Name: Maja Lindenmeyer, PhD; Phone Number: +49 (0) 40 7410 53908; Email: m.lindenmeyer@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20249
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Alexandre Klopp, MD; Phone Number: +49 (0) 40 7410 53908; Email: a.klopp@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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
• Personally signed informed consent

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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	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.	assessed at discharge, 3-months after discharge, and annual follow-up
Cardiovascular Outcomes	cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke	assessed at discharge, 3-months after discharge, and annual follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of vascular diseases	Occurrence of vascular disease, including coronary artery disease, peripheral artery disease, or cerebrovascular disease after AKI	assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Dementia	New diagnosis of dementia occurring during follow-up after AKI	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	assessed at discharge, 3 months after discharge, and annual follow-up
Incidence of Infections	New diagnosis of infections occurring during follow-up after AKI	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	assessed at discharge, 3 months after discharge, and annual follow-up

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Tobias B Huber, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: January 3, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; AKI; Prospective observational cohort study
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: PV6037-4337-BO-ff HARIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No