Imaging to track ARPKD kidney disease progression
Official title: Imaging Assessments of ARPKD Kidney Disease Progression
Run by The Cleveland Clinic · NCT07201025 · Data updated 2026-11-12
This project will test whether quick, quantitative non-contrast MRI scans can reliably track kidney disease progression in people aged 6 and older with ARPKD compared with healthy controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Status | Recruiting |
| Started | December 12, 2024 |
| Main results expected | February 28, 2029 |
| Study ends | February 28, 2029 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07201025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 6 and older with a clinical or genetic diagnosis of ARPKD, eGFR greater than 30 ml/min/1.73m2, no MRI contraindications, and the ability to lie still for 30 minutes.
✕Probably not a fit
Patients with eGFR below 30 ml/min/1.73m2, prior kidney transplant, severe obesity, history of prematurity under 32 weeks, systemic diseases that affect the kidney, or MRI contraindications would not be eligible and are unlikely to benefit from this imaging protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This five-year, NIH-funded prospective observational multicenter project will enroll 45 ARPKD patients and 15 healthy controls at Cleveland Clinic and Children's Hospital of Philadelphia. Participants age 6 and older who can tolerate a 30-minute non-contrast MRI will undergo standardized MRI protocols and clinical data collection, with ARPKD participants stratified into cohorts by eGFR. The team aims to develop rapid, quantitative, and reproducible MRI measures usable on standard clinical scanners that could act as biomarkers of disease progression across ages and disease severity. If validated, these measures could be used in future clinical trials to detect treatment effects more reliably than current endpoints.
Why it matters
Potential benefit: If successful, these MRI measures could let doctors track ARPKD progression earlier and more accurately and help speed development and testing of targeted therapies.
How similar studies have gone: MRI-based biomarkers have shown promise in related cystic kidney diseases like ADPKD, but robust, standardized MRI biomarkers for ARPKD specifically remain largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Katherine M Dell, MD — The Cleveland Clinic
- Study coordinator: Katherine M Dell, MD
- Email: pedsresearch@ccf.org
- Phone: 216-444-6123
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.