NCT07201025Recruiting
Imaging Assessments of ARPKD Kidney Disease Progression
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- 12 Dec 2024
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Polycystic kidney disease
- NCT number
- NCT07201025
What you commit to
- Study type: Observational
- Planned participants: 60
- From 12 Dec 2024 to the primary completion date, 28 Feb 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to MRI (e.g. metal implants)
- Prior kidney or other solid organ transplant
Other illness
- Systemic diseases known to place patient at risk for kidney disease (e.g. diabetes mellitus)
Lab values
- eGFR \<30ml/min/1.732 Healthy Controls
Age
- Obesity (BMI \>95th percentile for age for \<18 years old, or BMI\>30 for adults)
- History of prematurity (\<32 weeks gestational age)
Other
- ALL SUBJECTS
- Parental/patient refusal to sign an informed consent/ assent form ARPKD Patients
Who the study is looking for
- 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
Age in the registry: 6 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.