Multimodal Magnetic Resonance Imaging Assessments of Kidney Disease Severity in Autosomal Recessive Polycystic Kidney Disease.
Christina J MacAskill, Madison E Kretzler, Ashlee Parsons...
https://pubmed.ncbi.nlm.nih.gov/39698366Actively Recruiting
Age: 6Years +
All Genders
Healthy Volunteers
ID07201025
Imaging Assessments of ARPKD Kidney Disease Progression
Led by The Cleveland Clinic · Updated on 2025-11-21
60
Participants Needed
2
Research Sites
N/A
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 serious genetic condition affecting children, with no current specific treatments and significant risks including kidney failure by age 18. This prospective, observational study aims to develop new MRI-based measures that can quickly and reliably track kidney disease progression in ARPKD patients aged 6 and older. These biomarkers could improve how responses to future therapies are measured across different stages of the disease and ages. The study will enroll 45 ARPKD patients divided into three groups based on kidney function (early, mild, and moderate chronic kidney disease) and 15 healthy controls. ARPKD participants will have four annual visits over three years, including MRI scans, clinical data collection, blood and urine tests, and a special kidney function test called iohexol clearance. Healthy controls will have one study visit with similar assessments except for the kidney function test. The MRI scans use advanced techniques to evaluate kidney structure and function without contrast. Participants will provide clinical and demographic information, undergo blood and urine testing, and have multiple MRI scans to measure kidney health over time. Researchers will assess how well the new MRI biomarkers detect disease stage and progression compared to standard kidney function tests. The study also explores a new MRI method that may allow scanning young children without sedation. Safety and test repeatability will be monitored at two research sites, with the study lasting up to five years in total.
CONDITIONS
Brief Title
Imaging Assessments of ARPKD Kidney Disease Progression
Who Can Participate
Age: 6Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Participants must be 6 years old or older
- Able to stay still for 30 minutes during an MRI scan
- ARPKD patients must have a clinical or genetic diagnosis of ARPKD
- ARPKD patients must have an estimated glomerular filtration rate (eGFR) above 30 ml/min/1.73m2 within the past year
- Healthy controls must be free of known kidney disease and have no history of high blood pressure in the past year
You will not qualify if you...
- Any contraindications to MRI, such as metal implants
- Refusal to provide informed consent or assent
- ARPKD patients with prior kidney or other solid organ transplant
- ARPKD patients with eGFR below 30 ml/min/1.73m2
- Healthy controls with systemic diseases that increase kidney disease risk, such as diabetes
- Healthy controls who are obese (BMI over 95th percentile for children or over 30 for adults)
- Healthy controls born prematurely before 32 weeks gestational age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 4 years
Participants undergo multimodal kidney MRI scans and GFR measurements to assess kidney structure and function.
4 annual visits (in-person)
Long-term Monitoring
Duration - Up to 4 years
Participants are monitored over time to track changes in kidney disease progression using MRI biomarkers and GFR assessments.
4 annual visits (in-person)
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
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Research Team
K
Katherine M Dell, MD
R
Research Coordinator
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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Published Research Related To This Trial
Rapid B1-Insensitive MR Fingerprinting for Quantitative Kidney Imaging.
Christina J MacAskill, Michael Markley, Susan Farr...
https://pubmed.ncbi.nlm.nih.gov/34100680Multi-parametric MRI of kidney disease progression for autosomal recessive polycystic kidney disease: mouse model and initial patient results.
Christina J MacAskill, Bernadette O Erokwu, Michael Markley...
https://pubmed.ncbi.nlm.nih.gov/32283547