Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

NCT00169806 | Active Not Recruiting DMC

• 1 other identifier: 98-073
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrocalcinosis; Renal Calculi; Hypercalciuria; Hyperparathyroidism; Cystinuria

Keywords

Randall's Plaque; Kidney stones

Outcome Measures

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

  One year from study completion

Study Arms (1)

cohort

OTHER

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

Interventions

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.

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana Kidney Stone Institute: lead
• Indiana University School of Medicine: collaborator
• University of Chicago: collaborator

Study Sites (1)

IU Health North Hospital

Indianapolis, Indiana, 46032, United States

Location

MeSH Terms

Conditions

Nephrocalcinosis; Kidney Calculi; Hypercalciuria; Hyperparathyroidism; Cystinuria

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• James Lingeman, MD

  IU Health Physicians Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James Lingeman, MD

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 1998
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)