Attached Stone Project: Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by:
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00169754
First received: September 9, 2005
Last updated: September 16, 2008
Last verified: September 2008
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Do Calcium Oxalate Renal Calculi Originate From Randall's Plaque?

Resource links provided by NLM:


Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:
  • Detailed analysis of all stones from common calcium oxalate stone formers to determine stone composition and the site of stone attachment [ Time Frame: one year ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  • Male or female patients of Methodist Urology in Indianapolis, IN with kidney stones appropriate for percutaneous lithotripsy (PERC)
  • Age greater than 18 years

Exclusion Criteria:

  • Inability to give informed consent
  • Active infection
  • Bleeding diathesis
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169754

Locations
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana Kidney Stone Institute
Indiana University School of Medicine
Investigators
Principal Investigator: James E Lingeman, MD Methodist Urology, LLC
  More Information

No publications provided

Responsible Party: Dr. James E. Lingeman, Methodist Urology
ClinicalTrials.gov Identifier: NCT00169754     History of Changes
Other Study ID Numbers: 05-031
Study First Received: September 9, 2005
Last Updated: September 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:
Nephrolithiasis
Renal Calculi
Perc
Attached Stones

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on August 21, 2014