Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy

NCT07469059 | Recruiting

• 1 other identifier: ULM_VARIOUS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephritis

Keywords

kidney; ultrasound localization microscopy (ULM)

Outcome Measures

Primary Outcomes (16)

• CEUS Time intensity curves

  All CEUS outcomes will be generated in order to achieve time intensity curves in contrast enhanced ultrasound analysis

  baseline and up to 10 weeks after baseline

• CEUS Measurement1

  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. All CEUS measurements are established measurements in Time intensity analysis (TIC) of contrast enhanced ultrasound data.

  baseline and up to 10 weeks after baseline

• CEUS Measurement2

  Description: WiAUC (Wash-in Area Under the Curve (AUC(TI: TTP)))

  Baseline and up to 10 weeks after baseline

• CEUS Measurement 3

  RT (Rise Time = arterial inflow until maximum signal intensity), measured in seconds, higer RT means faster arterial inflow

  Baseline and up to 10 weeks after baseline

• CEUS Measurement5

  mTT (mean Transit Time local) (mTT-TI))

  Baseline and up to 10 weeks after baseline

• CEUS Measurement6

  TTP (Time to Peak)

  Baseline and up to 10 weeks after baseline

• CEUS Measurement7

  WiR (Wash-in-Rate )

  Baseline and up to 10 weeks after baseline

• CEUS Measurement8

  WiPI (Wash-in Perfusion Index (WiAUC/RT))

  Baseline and up to 10 weeks after baseline

• CEUS Measurement9

  WoAUC (Wash-out AUC (AUC(TTP:TO)))

  Baseline and up to 10 weeks after baseline

• CEUS Measurement10

  WiWoAUC (Wash-in- und Wash-out-AUC (WiAUC+WoAUC))

  Baseline and up to 10 weeks after baseline

• CEUS Measurement11

  FT (Fall Time - (TO-TTP))

  Baseline and up to 10 weeks after baseline

• CEUS Measurement12

  WOR (Wash-out-Rate) QOF (Quality Of Fit between the echo-power signal and f(t)

  Baseline and up to 10 weeks after baseline

• CEUS Measurement13

  QOF (Quality Of Fit between the echo-power signal and f(t)

  Baseline and up to 10 weeks after baseline

• Visualization and quantification of kidney perfusion with CEUS

  CEUS imaging for kidney perfusion in kidney disease

  Baseline and up to 10 weeks after baseline

• Visualization and quantification of kidney mikrovaskularisation with ULM

  ULM imaging for kidney perfusion and microvaskularisation in kidney disease

  Baseline and up to 10 weeks after baseline

• Visualization and quantification of glomeruli in the kidney with ULM

  ULM imaging for glomeruli in the kidney

  Baseline and up to 10 weeks after baseline

Secondary Outcomes (10)

• ULM and Ultrasound

  Baseline and up to 10 weeks after baseline

• ULM and CEUS

  Baseline and up to 10 weeks after baseline

• ULM and biopsy

  Baseline and up to 10 weeks after baseline

• 2D and 3D ULM

  Baseline and up to 10 weeks after baseline

• ULM and diagnosis

  Baseline and up to 10 weeks after baseline

Other Outcomes (1)

• urinary status

  Baseline and up to 10 weeks after baseline

Study Arms (1)

Study group

Patients with active sediment and/or proteinuria (\>1g/g Krea) and indication for renal biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One study population. Anticipated approx. n=30 adultswith above mentioned inclusion criteria with active sediment and/or proteinuria and indication for kidney biopsy

You may qualify if:

• Age ≥ 18 years
• Evidence of active urinary sediment and/or proteinuria \>1 g/g creatinine
• Indication for kidney biopsy as part of study-independent diagnostics
• Written informed consent

You may not qualify if:

• Known allergic disposition to SonoVue®
• Contraindication to the use of SonoVue®
• Pregnancy
• Breastfeeding mothers

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine

MeSH Terms

Conditions

Nephritis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Ferdinand Knieling, MD, PhD, MHBA

CONTACT

091318533118; ferdinand.knieling@uk-erlangen.de

Henriette Mandelbaum, MD, PhD

CONTACT

09131 85 33118; henriette.mandelbaum@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Dr. rer. biol. hum. Ferdinand Knieling MHBA

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: March 13, 2026
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)