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Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

This study is currently recruiting participants.
Verified August 2016 by Indiana Kidney Stone Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169806
First Posted: September 15, 2005
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Indiana University School of Medicine
University of Chicago
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

Resource links provided by NLM:


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 ]

Estimated Enrollment: 400
Study Start Date: November 1998
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169806


Contacts
Contact: Lori Rawlings, RN 317-962-0870 lrawlings@iuhealth.org

Locations
United States, Indiana
IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lori Rawlings, RN    317-962-0870    lrawlings@iuhealth.org   
Principal Investigator: James Lingeman, 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

Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00169806     History of Changes
Other Study ID Numbers: 98-073
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: February 16, 2017
Last Verified: August 2016

Keywords provided by Indiana Kidney Stone Institute:
Randall's Plaque
Kidney stones

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Hyperparathyroidism
Calculi
Hypercalciuria
Cystinuria
Nephrocalcinosis
Parathyroid Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Urological Manifestations
Signs and Symptoms
Renal Aminoacidurias
Renal Tubular Transport, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Calcinosis
Calcium Metabolism Disorders