Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00169806|
Recruitment Status : Recruiting
First Posted : September 15, 2005
Last Update Posted : July 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Nephrocalcinosis Renal Calculi Hypercalciuria Hyperparathyroidism Cystinuria||Other: videotape for mapping of renal anatomy and papillary biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis|
|Study Start Date :||November 1998|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
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
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169806
|Contact: Kim Smootfirstname.lastname@example.org|
|United States, Indiana|
|IU Health Methodist Hospital||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Kim Smoot 317-962-0869 email@example.com|
|Principal Investigator: James Lingeman, MD|
|Principal Investigator:||James Lingeman, MD||IU Health Physicians Urology|