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Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00169806
Enrollment
600
Registered
2005-09-15
Start date
1998-11-30
Completion date
2025-12-31
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystinuria, Hypercalciuria, Hyperparathyroidism, Nephrocalcinosis, Renal Calculi

Keywords

Randall's Plaque, Kidney stones

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.

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.

Interventions

OTHERvideotape 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

Indiana University School of Medicine
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
Indiana Kidney Stone Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 significantOne year from study completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026