Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis - Full Text View

Sponsor:	Indiana Kidney Stone Institute
Collaborators:	Indiana University School of Medicine University of Chicago
Information provided by:	Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:	NCT00169806

Purpose

Kidney stones are very common. They affect 3-5% of the population in the United States. Many people are hospitalized for the treatment of kidney stones and some may die. Better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. However, exactly what causes kidney stones is unknown.

The most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. The investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. They propose to study these areas of the papilla, called Randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

Condition	Intervention
Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria	Other: videotape for mapping of renal anatomy and papillary biopsy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

Resource links provided by NLM:

Genetics Home Reference related topics: cystinuria

MedlinePlus related topics: Anatomy Kidney Stones Urine and Urination

U.S. FDA Resources

Further study details as provided by Indiana Kidney Stone Institute:

Primary Outcome Measures:

To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients who do not form stones and other patients who do form stones to see if the differences are significant [ Time Frame: One year from study completion ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 1998
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
cohort Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities	Other: videotape for mapping of renal anatomy and papillary biopsy Subjects who enroll in this study will have their renal anatomy videotaped for mapping purposes. Stone location and characteristics will be documented as will papilla and calyces. One or more papillary biopsies will be taken for analysis.

Detailed Description:

In order to attempt to explain the pathogenesis of renal calculi, the investigators videotape and document the location and characteristics of each stone, papillae and calyces. One or more small papillary biopsies are taken for analysis to help determine the point of origin of the kidney stone and histological studies are undertaken to determine tissue differences amongst different types of stone formers. Approximately one month after surgery, metabolic studies are undertaken to further review potential causes of stone formation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients of Methodist Urology in Indianapolis, IN who are undergoing endoscopic procedures for nephrolithiasis or other urologic disease.
Upper urinary tract endoscopic or PERC procedure for kidney stones removal
General medical health allowing surgical procedure
Ability to complete all the necessary components of the study
Able to sign an informed consent

Exclusion Criteria:

Poor general medical health
Bleeding diathesis
Inability or unwillingness to comply with post-surgical follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169806

Contacts

Contact: Lori Rawlings, RN

317-962-0870

lrawlings@iuhealth.org

Locations

United States, Indiana
Methodist Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org
Principal Investigator: James Lingeman, MD
Sub-Investigator: Larry Munch, MD

Sponsors and Collaborators

Indiana Kidney Stone Institute

Indiana University School of Medicine

University of Chicago

Investigators

Principal Investigator:

James Lingeman, MD

IU Health Physicians Urology

More Information

No publications provided

Responsible Party:	James Lingeman, MD, IU Health Physicians Urology
ClinicalTrials.gov Identifier:	NCT00169806 History of Changes
Other Study ID Numbers:	98-073
Study First Received:	September 12, 2005
Last Updated:	March 24, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana Kidney Stone Institute:

Randall's Plaque
Kidney stones

Additional relevant MeSH terms:

Calculi
Cystinuria
Hypercalciuria
Hyperparathyroidism
Kidney Calculi
Nephrocalcinosis
Nephrolithiasis
Pathological Conditions, Anatomical
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases

Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Urological Manifestations
Signs and Symptoms
Parathyroid Diseases
Endocrine System Diseases
Urolithiasis
Urinary Calculi
Calcinosis
Calcium Metabolism Disorders

ClinicalTrials.gov processed this record on February 12, 2012