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NCT07201025: IMAGE-ARPKD

Imaging Assessments of ARPKD Kidney Disease Progression

Recruiting now Last updated 21 November 2025
What this trial tests

trial in Autosomal Recessive Polycystic Kidney Disease in 60 participants. Currently enrolling.

Timeline
12 December 2024
Primary endpoint
28 February 2029
28 February 2029

Quick facts

Lead sponsorThe Cleveland Clinic
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment60
Start date12 December 2024
Primary completion28 February 2029
Estimated completion28 February 2029
Sites2 locations across United States

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

6 and older, any sex, with Autosomal Recessive Polycystic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Autosomal Recessive Polycystic Kidney Disease

Currently open trials in the same condition.

Other The Cleveland Clinic trials

Trials by the same sponsor.

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Data sources for this page

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