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NCT Number: NCT00169806

Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Nephrocalcinosis Calcinosis Calcium Metabolism Disorders Calculi Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystinuria Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hypercalciuria Hyperparathyroidism Kidney Calculi Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nephrolithiasis Nutritional and Metabolic Diseases Parathyroid Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Aminoacidurias Renal Calculi Renal Tubular Transport, Inborn Errors Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health North Hospital

Indianapolis, Indiana, 46032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

videotape for mapping of renal anatomy and papillary biopsy

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indiana Kidney Stone Institute

Other

Collaborators

  • Indiana University
  • University of Chicago

Registry information

Official study title

Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

Important dates

Study start
1998
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2005
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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