Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:11 AM
Study NCT ID:
NCT07469059
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009393', 'term': 'Nephritis'}], 'ancestors': [{'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': 'Blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'urinary status', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'levels of erythrocytes and proteinuria in urine, microscopic examination of urine sediment'}], 'primaryOutcomes': [{'measure': 'CEUS Time intensity curves', 'timeFrame': 'baseline and up to 10 weeks after baseline', 'description': 'All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis'}, {'measure': 'CEUS Measurement1', 'timeFrame': 'baseline and up to 10 weeks after baseline', 'description': 'PE (Peak-Enhancement) is an established measurement in CEUS analysis. It describes the highest signal intensity after administration of contrast agents and is measured in arbitrary units.\n\nAll CEUS measurements are established measurements in Time intensity analysis (TIC) of contrast enhanced ultrasound data.'}, {'measure': 'CEUS Measurement2', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Description: WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))'}, {'measure': 'CEUS Measurement 3', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'RT (Rise Time = arterial inflow until maximum signal intensity), measured in seconds, higer RT means faster arterial inflow'}, {'measure': 'CEUS Measurement5', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'mTT (mean Transit Time local) (mTT-TI))'}, {'measure': 'CEUS Measurement6', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'TTP (Time to Peak)'}, {'measure': 'CEUS Measurement7', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'WiR (Wash-in-Rate )'}, {'measure': 'CEUS Measurement8', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'WiPI (Wash-in Perfusion Index (WiAUC/RT))'}, {'measure': 'CEUS Measurement9', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'WoAUC (Wash-out AUC (AUC(TTP:TO)))'}, {'measure': 'CEUS Measurement10', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))'}, {'measure': 'CEUS Measurement11', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'FT (Fall Time - (TO-TTP))'}, {'measure': 'CEUS Measurement12', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)'}, {'measure': 'CEUS Measurement13', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'QOF (Quality Of Fit between the echo-power signal and f(t)'}, {'measure': 'Visualization and quantification of kidney perfusion with CEUS', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'CEUS imaging for kidney perfusion in kidney disease'}, {'measure': 'Visualization and quantification of kidney mikrovaskularisation with ULM', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'ULM imaging for kidney perfusion and microvaskularisation in kidney disease'}, {'measure': 'Visualization and quantification of glomeruli in the kidney with ULM', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'ULM imaging for glomeruli in the kidney'}], 'secondaryOutcomes': [{'measure': 'ULM and Ultrasound', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with sonographic parameters (including resistance index a.o.)'}, {'measure': 'ULM and CEUS', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with parameters of contrast-enhanced ultrasound (CEUS)'}, {'measure': 'ULM and biopsy', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (including the number of segmented glomeruli) with histological parameters.'}, {'measure': '2D and 3D ULM', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Comparison of visualized and quantified microvascular dynamics (including glomeruli) using 2D and 3D ULM'}, {'measure': 'ULM and diagnosis', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Comparison of the vascular architecture visualized by ULM (including the number of segmented glomeruli) with the underlying diagnosis in patients with active sediment and/or proteinuria \\>1 g/g creatinine and indication for kidney biopsy.'}, {'measure': 'Comparison before and after treatment', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Comparison of microvascular dynamics via ULM/CEUS in the kidney before and after treatment (e.g., pharmacological therapy)'}, {'measure': 'Correlation between ULM and laboratory parameters', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Correlation of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) with laboratory parameters (including kidney function parameters, inflammatory markers, immunological parameters.'}, {'measure': 'ULM on different diagnoses', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'Comparison of the vascular architecture visualized by ULM and parameters of quantified microvascular perfusion dynamics of the kidney (e.g., number of segmented glomeruli) between different diagnoses.'}, {'measure': 'Assessment of renal function GFR', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'GFR (ml/min/1,73 m2)'}, {'measure': 'Assessment of renal function urea', 'timeFrame': 'Baseline and up to 10 weeks after baseline', 'description': 'urea (mg/dl)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kidney', 'ultrasound localization microscopy (ULM)'], 'conditions': ['Nephritis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is the non-invasive visualization and quantification of renal microvascular dynamics in adult kidneys with proteinuria and/or active sediment.', 'detailedDescription': 'In this study, the microvascular architecture of the kidney in adults with active urinary sediment or proteinuria is to be examined non-invasively using Ultrasound Localization Microscopy (ULM).\n\nKidney diseases can broadly be classified according to the affected nephron compartment into glomerular, tubular, and tubulointerstitial diseases. Glomerular diseases include, among others, the nephrotic and nephritic syndromes, which differ in their clinical and laboratory characteristics: while the nephrotic syndrome is typically characterized by marked proteinuria (\\>3.5 g/day), hypoalbuminemia, edema, and hyperlipidemia, the nephritic syndrome is dominated by hematuria with acanthocytes, mild to moderate proteinuria, arterial hypertension, and impaired renal function. Tubular and tubulointerstitial diseases, on the other hand, often manifest as acute kidney injury (e.g., in ischemic or toxic injury), polyuria, salt wasting, or metabolic acidosis, often accompanied by nonspecific symptoms such as fatigue or dehydration.\n\nIn addition to these classical nephron compartments, renal vascular structures may also be primarily or secondarily affected, as in vasculitis, thrombotic microangiopathies, or hypertensive nephropathy. Although these vascular structures are not directly part of the nephron, they are functionally closely linked to it and have a significant impact on renal function.\n\nTo assess kidney status, pathophysiology, and the site of injury non-invasively, urinary sediment is analyzed. Urinary sediment represents a central diagnostic tool that provides information on the localization of kidney damage, thereby functioning as a type of "liquid biopsy."\n\nIf there is clinical suspicion of acute or rapidly progressive renal failure, nephrotic syndrome, significant non-nephrotic proteinuria, glomerular hematuria, or if a systemic disease with possible renal involvement is present, a kidney biopsy is usually indicated for further diagnostic clarification. Obtaining tissue samples for histological examination is an invasive procedure associated with inpatient hospitalization, considerable burden for patients, and potential complications. Currently, alternative imaging methods cannot replace kidney biopsy. Furthermore, CT, PET, or MR imaging is associated with radiation exposure or considerable additional effort (e.g., sedation).\n\nUltrasound Localization Microscopy (ULM) enables visualization of vascular architecture using contrast-enhanced ultrasound. Recently, glomeruli-the smallest functional units of the kidney-were visualized and even counted in both rats and humans. Thus, ULM enables an assessment of renal function potentially comparable to kidney biopsy, in which glomeruli are also counted and examined. Beyond the kidney, the microvascular architecture of the human brain has also been depicted at previously unknown resolution using ULM. ULM therefore offers both qualitative and quantitative visualization of vascular architecture and perfusion dynamics. In the latest studies, 3D ULM imaging has been achieved, allowing volumetric visualization of vascular architecture and thereby overcoming the limitations of 2D imaging. This three-dimensional depiction of vascular structures may potentially provide more realistic insights into disease-related changes that would otherwise not be possible.\n\nIn the following, the term \'ULM\' is used inclusively for both 2D and 3D ULM. In this study, renal function and perfusion in patients with active urinary sediment and indication for kidney biopsy will be evaluated, compared, and correlated with results from histology (biopsy), laboratory tests, and ultrasound diagnostics. If possible, a follow up assessment via ULM/CEUS after treatment (for example pharmacological therapy) will be scheduled.\n\nWith ULM the investigators aim to visualize the microvascular architecture and glomeruli, and to investigate whether differences detectable by ULM can be identified for the various causes of active sediment. In addition, the investigators seek to establish alterations in perfusion dynamics as potential imaging markers of kidney function.\n\nIn the future, this could enable non-invasive differentiation of the underlying disease and assessment of renal function, potentially reducing the need for invasive, high-risk procedures and allowing faster diagnosis in patients with an indication for kidney biopsy due to active sediment or proteinuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'One study population. Anticipated approx. n=30 adultswith above mentioned inclusion criteria with active sediment and/or proteinuria and indication for kidney biopsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Evidence of active urinary sediment and/or proteinuria \\>1 g/g creatinine\n* Indication for kidney biopsy as part of study-independent diagnostics\n* Written informed consent\n\nExclusion Criteria:\n\n* Known allergic disposition to SonoVue®\n* Contraindication to the use of SonoVue®\n* Pregnancy\n* Breastfeeding mothers'}, 'identificationModule': {'nctId': 'NCT07469059', 'acronym': 'VARIOUS', 'briefTitle': 'Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy', 'orgStudyIdInfo': {'id': 'ULM_VARIOUS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients with active sediment and/or proteinuria (\\>1g/g Krea) and indication for renal biopsy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Ferdinand Knieling, MD, PhD, MHBA', 'role': 'CONTACT', 'email': 'ferdinand.knieling@uk-erlangen.de', 'phone': '091318533118'}, {'name': 'Henriette Mandelbaum, MD, PhD', 'role': 'CONTACT', 'email': 'henriette.mandelbaum@uk-erlangen.de', 'phone': '09131 85 33118'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Dr. rer. biol. hum. Ferdinand Knieling MHBA', 'investigatorFullName': 'Ferdinand Knieling', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}