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Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

NCT00169806 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-01-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Indiana University School of Medicine

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Indiana Kidney Stone Institute

    lead OTHER

Principal Investigators

  • James Lingeman, MD · IU Health Physicians Urology

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-11-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00169806 on ClinicalTrials.gov