NephrocalcinosisNCT00169806
Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis
A study testing videotape for mapping of renal anatomy and papillary biopsy in people with Nephrocalcinosis and Renal Calculi, run by Indiana Kidney Stone Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrocalcinosis, Renal Calculi, Hypercalciuria
- What is being tested?
- videotape for mapping of renal anatomy and papillary biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Poor general medical health
- Bleeding diathesis
- Inability or unwillingness to comply with post-surgical follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health North Hospital
Indianapolis, Indiana, 46032
About this study
Official title: Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis
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.
Read the 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.
- Conditions
- Nephrocalcinosis, Renal Calculi, Hypercalciuria, Hyperparathyroidism, Cystinuria
- Being tested
- videotape for mapping of renal anatomy and papillary biopsy
- Keywords
- Randall's Plaque, Kidney stones
- Medical subject headings
- Nephrocalcinosis, Kidney Calculi, Hypercalciuria, Hyperparathyroidism, Cystinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videotape for mapping of renal anatomy and papillary biopsyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| cohort | Other | Subjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities Receives: Other: videotape for mapping of renal anatomy and papillary biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year from study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 1998
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrocalcinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Chicago
- Responsible party
- Principal investigator, James Lingeman, Indiana Kidney Stone Institute
- Investigators
- James Lingeman, MD, Principal investigator, IU Health Physicians Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169806
- Sponsor's protocol ID
- 98-073
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2005
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randall's Plaques: Pathogenesis and Relationship to Nephrolithiasis
- ClinicalTrials.gov ID
- NCT00169806
- Acronym / sponsor ID
- 98-073
- Conditions
- Nephrocalcinosis, Renal Calculi, Hypercalciuria, Hyperparathyroidism, Cystinuria
- Keywords
- Randall's Plaque, Kidney stones
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Collaborators
- Indiana University, University of Chicago
- Study start
- Nov 1998
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | Other | Other: videotape for mapping of renal anatomy and papillary biopsySubjects who are scheduled to undergo a percutaneous kidney stone removal who do not have complicated comorbidities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Poor general medical health
- Bleeding diathesis
- Inability or unwillingness to comply with post-surgical follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videotape for mapping of renal anatomy and papillary biopsySubjects 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. | Other | cohort |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Lingeman, MD principal investigator
IU Health Physicians Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videotape for mapping of renal anatomy and papillary biopsy in people with Nephrocalcinosis and Renal Calculi, run by Indiana Kidney Stone Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.