Status:
RECRUITING
Imaging Assessments of ARPKD Kidney Disease Progression
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Autosomal Recessive Polycystic Kidney Disease
Eligibility:
All Genders
6+ years
Brief Summary
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 ab...
Detailed Description
Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder that affects approximately 1/20,000 children and shares common cellular pathophysiology with other cystic...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ALL SUBJECTS
- Ages \>6 years old
- Able to lay still for 30 minutes in an MRI scanner ARPKD Patients
- Clinical and/or genetic diagnosis of ARPKD
- eGFR (creatinine based) \>30ml/min/1.732 performed within the last year Healthy Controls
- Otherwise healthy with no known structural or functional kidney disease
- No history of hypertension or documented high blood pressure within the last year
- Exclusion criteria:
- ALL SUBJECTS
- Contraindications to MRI (e.g. metal implants)
- Parental/patient refusal to sign an informed consent/ assent form ARPKD Patients
- Prior kidney or other solid organ transplant
- eGFR \<30ml/min/1.732 Healthy Controls
- Systemic diseases known to place patient at risk for kidney disease (e.g. diabetes mellitus)
- Obesity (BMI \>95th percentile for age for \<18 years old, or BMI\>30 for adults)
- History of prematurity (\<32 weeks gestational age)
Exclusion
Key Trial Info
Start Date :
December 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07201025
Start Date
December 12 2024
End Date
February 28 2029
Last Update
November 21 2025
Active Locations (2)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104