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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 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.

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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.

Study Locations (2)

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-12-12
Est. Completion 2029-02-28

Sponsor

The Cleveland Clinic

688 total trials

What the Registry Record Tells You About NCT07201025

The ClinicalTrials.gov registry entry for NCT07201025 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autosomal Recessive Polycystic Kidney Disease appearing as the primary indexed condition, and to 0 interventions.

NCT07201025 reports 2 study locations spanning 2 distinct geographic areas - top geographies include 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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