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| Sponsors and Collaborators: |
Indiana Kidney Stone Institute Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana Kidney Stone Institute |
| ClinicalTrials.gov Identifier: | NCT00169754 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Renal Calculi |
Other: mapping kidney anatomy |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque? |
| Enrollment: | 32 |
| Study Start Date: | April 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
cohort
mapping and data collection
|
Other: mapping kidney anatomy
videotape of surgical procedure to document location of attached stones and condition of calyces and papilla.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | James E Lingeman, MD | Methodist Urology, LLC |
More Information
| Responsible Party: | Methodist Urology ( Dr. James E. Lingeman ) |
| Study ID Numbers: | 05-031 |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00169754 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Nephrolithiasis Renal Calculi Perc Attached Stones |
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Pathological Conditions, Anatomical Calcium, Dietary Urinary Calculi Urologic Diseases Urolithiasis |
Kidney Diseases Calculi Nephrolithiasis Kidney Calculi |
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Pathological Conditions, Anatomical Urinary Calculi Urologic Diseases Urolithiasis |
Kidney Diseases Calculi Nephrolithiasis Kidney Calculi |