Prospective Research Rare Kidney Stones (ProRKS)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Mayo Clinic
- Study ID
- NCT02780297
- Status
- Recruiting
Conditions
- Adenine Phosphoribosyltransferase Deficiency
- Cystinuria
- Dent Disease
- Hyperoxaluria
- Lowe Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Study Details
The purpose of this study is to determine the natural history of the hereditary forms of nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria, Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow us to better evaluate mechanisms of renal dysfunction in these disorders.
Key Dates
- Start date
- May 31, 2016
- Status verified
- Aug 2025
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 220 participants (estimated)
Arms
- Arm: Primary Hyperoxaluria PatientsPatients with confirmed diagnosis of Primary Hyperoxaluria.
- Arm: Dent Disease PatientsPatients with confirmed diagnosis of Dent Disease.
- Arm: Cystinuria PatientsPatients with confirmed diagnosis of Cystinuria.
- Arm: APRT deficiency PatientsPatients with confirmed diagnosis of adenine phosphoribosyltransferase deficiency (APRTd)
- Arm: Lowe Syndrome or Dent 2 patientsPatients with confirmed diagnosis of Lowe Syndrome or Dent 2.
- Arm: Dent 1 carriersPatients with confirmed diagnosis of Dent 1. Dent 1 carriers
- Arm: Enteric Hyperoxaluria PatientsPatients with confirmed diagnosis enteric hyperoxaluria.
Primary Outcome Measure
inflammatory blood and urinary biomarkers [ Time Frame: Annually for 5 years ]
Central Contacts
- Barb Seide800-270-4637
- Julie Olson, RN800-270-4637
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama @ Birmingham | Birmingham | Alabama | 35294 | Dean Assimos, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | Ivan Porter, MD William Haley, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | Heather Price, MS Craig Langman, M.D. (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital, Harvard Medical School | Boston | Massachusetts | 02115 | Michael Somers, MD Michelle Baum, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Hyperoxaluria Center | Rochester | Minnesota | 55905 | Dawn Milliner, MD (PRINCIPAL_INVESTIGATOR) |
| New York University | New York | New York | 10010 | Lada Beara-Lasic, MD David Goldfarb, MD (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Children's Hosptial Medical Center | Cincinnati | Ohio | 45229 | Prasad Decarajan, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Lawrence Copelovitch, MD (PRINCIPAL_INVESTIGATOR) |
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