Attached Stone Project: Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?
Public ClinicalTrials.gov record NCT00169754. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Urolithiasis is a common condition in the United States, and is associated with significant morbidity and even mortality. The most commonly occurring urinary calculi are comprised of calcium oxalate salts, and until recently, the pathogenesis of calcium oxalate calculi was poorly understood. New evidence, however, suggests that the development of calcium oxalate calculi may be intimately associated with hydroxyapatite (HA) plaque, also known as Randall's plaque, which is located on the renal papillae. The investigators have previously demonstrated that Randall's plaque originates in the thin ascending limb of the loop of Henle, and they have shown that Randall's plaque is composed of HA (Evan, Lingeman et al. 2003). As well, the amount of Randall's plaque correlates with elevated levels of urinary calcium and decreased urinary volume, risk factors for the formation of calcium oxalate calculi (Kuo, Lingeman et al. 2003). In the course of these previous studies, the investigators have anecdotally noted that calcium oxalate stones are often found attached to Randall's plaque, an observation that others have reported as well (Prien 1949; Carr 1954; Cifuentes Delatte, Minon-Cifuentes et al. 1987). However, there has been no in-vivo, rigorous documentation of this "attached stone" relationship. Attached calculi represent an important point in the pathogenesis of calcium oxalate calculi, as they correspond to a moment in time where there is a continuum between the HA plaque of Randall and the calcium oxalate stone, thus linking the origin of plaque with the development of stone. A better understanding of the phenomenon of attached calculi will lead to a better understanding of how and why calcium oxalate stones form, which may ultimately direct future interventions to attenuate stone activity.
Study identification
- NCT ID
- NCT00169754
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2005
- Primary completion
- Sep 30, 2007
- Completion
- Sep 30, 2007
- Last update posted
- Sep 16, 2008
2005 – 2007
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Methodist Hospital | Indianapolis | Indiana | 46202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00169754, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2008 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00169754 live on ClinicalTrials.gov.