Status:
ACTIVE_NOT_RECRUITING
Intrarenal Microvasculature in ADPKD
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
18-40 years
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 ...
Detailed Description
An intact intrarenal microcirculation is vital to preserving normal kidney function, and microvascular dysfunction, damage, and loss are known to contribute to renal function decline. In ADPKD, extens...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Patients with ADPKD):
- 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
- Inclusion Criteria (Healthy Volunteers):
- 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
- Exclusion Criteria (Patients with ADPKD):
- 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
- Exclusion Criteria (Healthy Volunteers):
- 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. \[For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.\].
- History of hypersensitivity allergic reactions to ultrasound contrast agents
- High risk cardiac disease (such as unstable hospital in-patients or ICU patients
Exclusion
Key Trial Info
Start Date :
November 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05288998
Start Date
November 30 2021
End Date
December 1 2025
Last Update
October 24 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905