Intrarenal Microvasculature in ADPKD (NCT05288998) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intrarenal Microvasculature in ADPKD
United States34 participantsStarted 2021-11-30
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 me…
What they're measuring
1
Assessment of intrarenal microvascular density in HV and patients with ADPKD
Timeframe: Baseline
2
Assessment of intrarenal microvascular flow speed in HV and patients with ADPKD
Timeframe: Baseline
3
Assessment of intrarenal microvascular perfusion in HV and patients with ADPKD
Timeframe: Baseline
4
Assessment of intrarenal tortuosity indices in HV and patients with ADPKD