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Imaging Assessments of ARPKD Kidney Disease Progression

Recruitingn/aAges 6 Years - anyAllThe Cleveland Clinic
NCT07201025 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

2 sites
Cleveland Clinic
Cleveland, United States
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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