Actively Recruiting
Imaging Assessments of ARPKD Kidney Disease Progression
Led by The Cleveland Clinic · Updated on 2025-11-21
60
Participants Needed
2
Research Sites
219 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder for which there are currently no disease specific treatments. Clinical trials have been limited by the absence of robust measures of disease progression. The overall goal of this 5 year NIH-funded prospective, observational multicenter study conducted at CC (primary site) and Children's Hospital of Philadelphia (CHOP) (collaborating site) is establish a set of rapid, quantitative, and reproducible novel kidney MRI measures applicable to standard clinical MRI scanners, which could serve as potential biomarkers to measure response to therapy in patients across the disease spectrum and all ages. The investigators will recruit a total of 45 ARPKD patients and 15 healthy controls at the the two sites . All subjects will be \> or = 6yrs old with no contraindications to undergoing MRI (non contrast). ARPKD subjects will be recruited into one of 3 cohorts based on their estimated glomerular filtration rate (eGFR): early CKD (eGFR\> or =90ml/min/1.73m2), mild CKD (60-89ml/min/1.73m2) and moderate CKD (30-59ml/min/1.73m2). For ARPKD subjects, participation will last 3 years and consist of a baseline and 3 subsequent annual visits. Healthy controls will only have 1 study visit. Study visits for all participants will include collection of clinical and demographic data, clinical blood and urine tests (E.g. serum creatinine) and MRI imaging. ARPKD (but not healthy subjects) will also undergo a measured GFR test (iohexol clearance) to accurately assess their kidney function.
CONDITIONS
Official Title
Imaging Assessments of ARPKD Kidney Disease Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 years or older
- Ability to lie still for 30 minutes in an MRI scanner
- For ARPKD patients: clinical and/or genetic diagnosis of ARPKD
- For ARPKD patients: eGFR (creatinine based) greater than 30 ml/min/1.73m2 within the last year
- For healthy controls: no known structural or functional kidney disease
- For healthy controls: no history of hypertension or high blood pressure within the last year
You will not qualify if you...
- Contraindications to MRI such as metal implants
- Refusal to sign informed consent or assent
- For ARPKD patients: prior kidney or other solid organ transplant
- For ARPKD patients: eGFR less than 30 ml/min/1.73m2
- For healthy controls: systemic diseases that increase risk for kidney disease, such as diabetes mellitus
- For healthy controls: obesity defined as BMI over 95th percentile for age if under 18, or BMI over 30 for adults
- For healthy controls: history of prematurity (less than 32 weeks gestational age)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Katherine M Dell, MD
CONTACT
R
Research Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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