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Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

Primary Purpose

Nephrocalcinosis, Renal Calculi, Hypercalciuria

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
videotape for mapping of renal anatomy and papillary biopsy
Sponsored by
Indiana Kidney Stone Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nephrocalcinosis focused on measuring Randall's Plaque, Kidney stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IU Health North HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cohort

Arm Description

Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
March 8, 2023
Sponsor
Indiana Kidney Stone Institute
Collaborators
Indiana University School of Medicine, University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00169806
Brief Title
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
Official Title
Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1998 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana Kidney Stone Institute
Collaborators
Indiana University School of Medicine, University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrocalcinosis, Renal Calculi, Hypercalciuria, Hyperparathyroidism, Cystinuria
Keywords
Randall's Plaque, Kidney stones

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cohort
Arm Type
Other
Arm Description
Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities
Intervention Type
Other
Intervention Name(s)
videotape for mapping of renal anatomy and papillary biopsy
Intervention Description
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Smoot
Phone
317-688-3846
Email
ksmoot@iuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Lingeman, MD
Organizational Affiliation
IU Health Physicians Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health North Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Smoot
Phone
317-688-3846
Email
ksmoot@iuhealth.org
First Name & Middle Initial & Last Name & Degree
James Lingeman, MD

12. IPD Sharing Statement

Learn more about this trial

Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

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