Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Hyperparathyroidism Clinical Trial

Official title:

Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00169806
• Other study ID #: 98-073
• Status: Recruiting
• Phase: N/A
• Start date: November 1998
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Indiana Kidney Stone Institute
• Contact: Kim Smoot
• Phone: 317-688-3846
• Email: ksmoot[@]iuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Cystinuria
• Hypercalciuria
• Hyperparathyroidism
• Kidney Calculi
• Nephrocalcinosis
• Nephrolithiasis
• Renal Calculi

Intervention

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.

Locations

Country	Name	City	State
United States	IU Health North Hospital	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana Kidney Stone Institute	Indiana University School of Medicine, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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