Intrarenal Microvasculature in ADPKD

NCT05288998 | Active Not Recruiting DMC

• 2 other identifiers: 21-0051171R21DK129886-01
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the use of Super-resolution ultrasound (SRU) to assess the intrarenal microvasculature in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and healthy volunteers.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

ADPKD; Intrarenal microvasculature

Outcome Measures

Primary Outcomes (4)

• Assessment of intrarenal microvascular density in HV and patients with ADPKD

  Renal vessel density as percentage, determined by SRU.

  Baseline

• Assessment of intrarenal microvascular flow speed in HV and patients with ADPKD

  Microvascular flow speed (mm/s), determined by SRU.

  Baseline

• Assessment of intrarenal microvascular perfusion in HV and patients with ADPKD

  Intrarenal perfusion (mm/s), determined by SRU.

  Baseline

• Assessment of intrarenal tortuosity indices in HV and patients with ADPKD

  Tortuosity indices defined as sum of angles metric (SOAM) (rad/mm), determined by SRU

  Baseline

Secondary Outcomes (3)

• Inter-sonographer variability of the intrarenal microvasculature

  Baseline

• Day-to-day variability of intrarenal microvasculature in healthy volunteers

  Baseline to 7 days

• Patient-to-patient variability in patients with ADPKD

  Baseline

Study Arms (2)

Patients with a previous diagnosis of ADPKD

Patients that have been diagnosed with ADPKD and meet the study's inclusion criteria

Healthy Volunteers

Subjects without a family or personal history of kidney disease or concomitant systemic disorder that might affect the kidney

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a previous diagnosis of ADPKD that meet the inclusion criteria, and healthy volunteers

You may qualify if:

• Male and female subjects 18 - 40 years of age, inclusive
• Previous diagnosis of ADPKD (based on Ravine et al. criteria)
• Class 1 according to imaging classification
• Estimated GFR\> 90 mL/min/m2 (CKD-Epi equation)
• Ability to provide written, informed consent
• Male and female subjects 18 - 40 years of age, inclusive
• Estimated GFR\> 90 mL/min/m2 (CKD-Epi equation)
• Ability to provide written, informed consent

You may not qualify if:

• Class 2 according to imaging classification
• A concomitant systemic disease affecting the kidney (e.g., lupus, hepatitis B or C, amyloidosis)
• Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
• Predicted urine protein excretion in urinalysis \>1 g/24 hrs.
• Subjects having contraindications to or interference with MRI assessments. \[For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.\].
• History of hypersensitivity allergic reactions to ultrasound contrast agents
• High-risk cardiac disease (such as unstable hospital in-patients or ICU patients
• Patients that are part of an interventional study or are taking tolvaptan
• Female subjects that are pregnant
• Family and/or personal history of kidney disease
• Concomitant systemic disease that may affect the kidney
• Diabetes mellitus
• Predicted urine protein excretion in \>1 g/24 hrs, and or Abnormal urinalysis
• Pregnant or lactating women
• Subjects having contraindications to or interference with MRI assessments. \[For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.\].

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and plasma samples

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Maria V Irazabal, M.D., Ph.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 21, 2022
• Study Start: November 30, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)