Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:39 AM
Study NCT ID:
NCT07338669
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hamburg Acute Renal Injury Study (HARIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma (EDTA), serum, blood cells, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-03', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2026-01-03', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kidney Function Recovery after AKI', 'timeFrame': 'assessed at discharge, 3-months after discharge, and annual follow-up', 'description': 'Improvement of kidney function after acute kidney injury, defined by partial or complete return of the kidney function toward baseline values'}, {'measure': 'Persistent Kidney Function Decline', 'timeFrame': 'assessed at discharge, 3-months after discharge, and annual follow-up', 'description': 'Sustained impairment of kidney function following acute kidney injury, characterized by incomplete recovery and persistently reduced kidney function over follow-up.'}, {'measure': 'Development or Progression of Chronic Kidney Disease', 'timeFrame': 'assessed at 3-months after discharge, and annual follow-up', 'description': 'New onset or worsening of chronic kidney disease during follow-up, assessed based on changes in kidney function over time.'}, {'measure': 'End-stage kidney disease (ESKD)', 'timeFrame': 'assessed at discharge, 3-months after discharge, and annual follow-up', 'description': 'Occurrence of ESKD, characterized by the initiation of maintenance kidney replacement therapy, kidney transplantation or a persistent eGFR \\< 15 ml/min/1.73m2'}, {'measure': 'Renal mortality', 'timeFrame': 'assessed at discharge, 3-months after discharge, and annual follow-up', 'description': 'Death attributable to kidney-related causes as determined by medical record review.'}, {'measure': 'Cardiovascular Outcomes', 'timeFrame': 'assessed at discharge, 3-months after discharge, and annual follow-up', 'description': 'cardiovascular death, myocardial infarction, heart failure, arrhythmia, stroke'}], 'secondaryOutcomes': [{'measure': 'Incidence of vascular diseases', 'timeFrame': 'assessed at discharge, 3 months after discharge, and annual follow-up', 'description': 'Occurrence of vascular disease, including coronary artery disease, peripheral artery disease, or cerebrovascular disease after AKI'}, {'measure': 'Incidence of Dementia', 'timeFrame': 'assessed at discharge, 3 months after discharge, and annual follow-up', 'description': 'New diagnosis of dementia occurring during follow-up after AKI'}, {'measure': 'Incidence of Cancer', 'timeFrame': 'assessed at discharge, 3 months after discharge, and annual follow-up', 'description': 'New diagnosis of malignant disease occurring during follow-up after AKI'}, {'measure': 'Incidence of Infections', 'timeFrame': 'assessed at discharge, 3 months after discharge, and annual follow-up', 'description': 'New diagnosis of infections occurring during follow-up after AKI'}, {'measure': 'Incidence of psychosomatic or Psychiatric Disorders', 'timeFrame': 'assessed at discharge, 3 months after discharge, and annual follow-up', 'description': 'New diagnosis of psychosomatic or psychiatric disorders occurring during follow-up after AKI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Kidney Injury', 'AKI', 'Prospective observational cohort study'], 'conditions': ['Acute Kidney Injury', 'Acute Kidney Injury (AKI)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Age ≥ 18 years at time of enrollment\n* Personally signed informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07338669', 'acronym': 'HARIS', 'briefTitle': 'Hamburg Acute Renal Injury Study (HARIS)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Hamburg Acute Renal Injury Study', 'orgStudyIdInfo': {'id': 'PV6037-4337-BO-ff HARIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AKI group', 'description': '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.'}, {'label': 'Control group', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20249', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexandre Klopp, MD', 'role': 'CONTACT', 'email': 'a.klopp@uke.de', 'phone': '+49 (0) 40 7410 53908'}], 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Christian Schmidt-Lauber, MD', 'role': 'CONTACT', 'email': 'c.schmidt-lauber@uke.de', 'phone': '+49 (0) 40 7410 53908'}, {'name': 'Maja Lindenmeyer, PhD', 'role': 'CONTACT', 'email': 'm.lindenmeyer@uke.de', 'phone': '+49 (0) 40 7410 53908'}], 'overallOfficials': [{'name': 'Tobias B Huber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}