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NCT07201025 · ClinicalTrials.gov registry record
Imaging Assessments of ARPKD Kidney Disease Progression
A clinical trial of Autosomal Recessive Polycystic Kidney Disease, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- 60
- Enrollment target
- 2
- Study locations
NCT07201025: Recruiting study of Autosomal Recessive Polycystic Kidney Disease, sponsored by The Cleveland Clinic.
NCT07201025 is a study of Autosomal Recessive Polycystic Kidney Disease that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 60 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07201025, a study of Autosomal Recessive Polycystic Kidney Disease, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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 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.
Conditions Studied
Study Locations (2)
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2029-02-28 |
What NCT07201025 shows while recruiting
NCT07201025 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 1 condition, with Autosomal Recessive Polycystic Kidney Disease appearing as the primary indexed condition, and to 0 interventions.
NCT07201025 reports a single indexed study location in Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07201025 about?
NCT07201025 is a clinical study titled "Imaging Assessments of ARPKD Kidney Disease Progression". 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 prospect...
What is the current status of trial NCT07201025?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2024-12-12. Estimated completion is 2029-02-28.
What conditions does trial NCT07201025 study?
This clinical trial studies the following conditions: Autosomal Recessive Polycystic Kidney Disease.
Who is sponsoring clinical trial NCT07201025?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07201025 being conducted?
This trial has 2 study locations across Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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