Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Indiana Kidney Stone Institute
Sponsor:
Collaborators:
Indiana University School of Medicine
University of Chicago
Information provided by (Responsible Party):
Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier:
NCT00169806
First received: September 12, 2005
Last updated: June 23, 2014
Last verified: June 2014
  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:


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: 400
Study Start Date: November 1998
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
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: 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

No publications provided

Responsible Party: Indiana Kidney Stone Institute
ClinicalTrials.gov Identifier: NCT00169806     History of Changes
Other Study ID Numbers: 98-073
Study First Received: September 12, 2005
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014