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Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 23, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Amendment history

  1. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv30

  2. Minor

    Study site revised

    Show what changed: Study sites
    IU Health MethodistNorth Hospital

    Study Status, Contacts/Locationsv29

  3. Minor

    2 amendments

    2 re-verifications since 2020-07-30, no change to tracked fields

    v27-v28

  4. Notable

    Primary and study completion dates: Dec 2019 to Dec 2025

    Study Statusv26

  5. Notable

    Enrollment target: 400 to 600

    Study Status, Sponsor/Collaborators, Study Designv25

Show 23 earlier versions

  1. Minor

    Site contact updated

    Study Status, Contacts/Locationsv24

  2. Notable

    Primary and study completion dates: Dec 2018 to Dec 2019

    Study Statusv23

  3. Notable

    Primary and study completion dates: Dec 2016 to Dec 2018

    Study Statusv22

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v21

  5. Notable

    Primary and study completion dates: Dec 2015 to Dec 2016

    Study Status, Study Designv20

  6. Minor

    3 amendments

    3 re-verifications since 2014-06-23, no change to tracked fields

    v17-v19

  7. Notable

    Primary and study completion dates: Dec 2014 to Dec 2015

    Study Statusv16

  8. Notable

    Primary completion date: Dec 2012 to Dec 2014

    Study Statusv15

  9. Notable

    Enrollment target: 200 to 400

    Study site revised

    Show what changed: Study sites
    IU Health Methodist Hospital

    Study Status, Sponsor/Collaborators, Study Design, Contacts/Locationsv14

  10. Minor

    Site contact updated

    Study Status, Sponsor/Collaborators, Contacts/Locationsv13

  11. Notable

    Primary completion date: Dec 2009 to Dec 2012

    Completion date: Dec 2010 to Dec 2014

    Study Statusv12

  12. Minor

    2 amendments

    2 re-verifications since 2009-01-27, no change to tracked fields

    v10-v11

  13. Minor

    Primary completion date: Dec 2009

    Completion date: Jun 2009 to Dec 2010

    Study Status, Sponsor/Collaboratorsv9

  14. Notable

    Phase: Not specified to Not applicable

    Primary endpoint revised; Enrollment target: 155 to 200; Completion date: Jun 2007 to Jun 2009; and 2 more

    Show all 6 changes in this update
    • Notable Phase: Not specified to Not applicable
    • Notable Primary endpoint revised
      Show what changed
      To find out why people form stones by comparing 24 urine collections, biopsy and anatomy to other patients thatwho do not form stones and other patients thatwho do form stones to see if the differences are significant.
    • Minor Enrollment target: 155 to 200
    • Minor Completion date: Jun 2007 to Jun 2009
    • Minor Eligibility criteria expanded, about 7 words
      Show what changed
      Inclusion Criteria: Patients of Methodist Urology in Indianapolis, IN who are undergoing endoscopic procedures for nephrolithiasis or [...]
    • Minor Study description shortened, about 181 words
      Show what changed
      KidneyIn stonesorder 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 verytaken common. Theyfor affectanalysis 3-5%to help determine the point 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 m [...] [...]

    Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv8

  15. Minor

    Site contact updated

    Study Status, Contacts/Locationsv7

  16. Minor

    Completion date: Jun 2006 to Jun 2007

    Study Statusv6

  17. Minor

    Completion date: Jun 2006

    Site contact updated

    Study Status, Study Design, Contacts/Locationsv5

  18. Notable

    Phase: Not applicable to Not specified

    Eligibility criteria shortened, about 1 word; Study description expanded, about 7 words; Study title expanded, about 5 words

    Show what changed: Eligibility criteria
    [...] r other urologic disease. Upper urinary tract endoscopic or percPERC procedure for kidney stones removal generalGeneral medical health allowing surgical procedure Ability to complete all the necessary components of the study Be ableAble to sign an informed consent Exclusion Criteria: Poor genera [...]
    Show what changed: Study description
    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 [...] ey stones is unknown. The most common type of kidney stones containcontains calcium, which sometimes is attached to a part of the kidne [...] important in producing the final urine, called the papilla. WeThe investigators have noticed that persons who form kidney stones seem to have more papilla with sto [...] [...]
    Show what changed: Study title
    Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis

    Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv4

  19. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] ng surgical procedure Ability to complete all the necessary componenetscomponents of the study Be able to sign an informed consent Exclusion [...]

    Study Status, Eligibilityv3

  20. Minor

    Study description revised

    Show what changed: Study description
    [...] ho form kidney stones seem to have more papilla with stones atttachedattached. We propose to study these areas of the papilla, called Ran [...]

    Study Status, Study Descriptionv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00169806
Lead Sponsor Indiana Kidney Stone Institute
Collaborators: Indiana University, University of Chicago
Conditions Nephrocalcinosis, Renal Calculi, Hypercalciuria, Hyperparathyroidism, Cystinuria
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov