Monogenic Kidney Stone - Genetic Testing

NCT ID: NCT03305835

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-11

Study Completion Date

2028-02-29

Brief Summary

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This study will attempt to identify the specific gene (coded in the DNA) and changes (mutations) within that gene that are the cause of monogenic kidney stone disease. This study will help researchers determine the characteristics of the stone disease associated with specific genes and mutations. This information may help develop more effective treatments for monogenic kidney stone diseases.

Detailed Description

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Have a blood test (about 2 teaspoons; ½ to 1 teaspoons for children) or buccal cell collection for DNA or RNA isolation • Complete a kidney stone history questionnaire

In addition to the above testing, family members may be asked to participate in the following:

• Complete a 24 hr. urine collection Your samples will undergo genetic testing. We will share the results with your local doctor. All family members, of a patient whose genetic testing showed no known mutations, will not be tested. These samples will be stored for future research.

Conditions

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Rare Kidney Stone Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Participants meet at least one of the following criteria:

1. Patients \<18yrs with a history of kidney stones, and/or nephrocalcinosis, OR
2. Patients \>18yrs with a history of kidney stones, and/or nephrocalcinosis and at least one of the following:

1. Family history of stones or nephrocalcinosis or unexplained kidney failure
2. Growth retardation
3. Metabolic bone disease
4. Unusual stone composition or pathologic or urinary crystals
5. Proteinuria
6. Reduced glomerular filtration rate (GFR)
7. Hypomagnesemia or hypophosphatemia or hypercalcemia
8. Increased oxalate
9. Renal cysts, OR
3. Patients with a high clinical suspicion for a monogenic kidney stone disease or a disorder of calcium metabolism OR
4. Patients previously enrolled in the Rare Kidney Stone Consortium 6406 protocol (identified as legacy samples), "Genetic Characterization and Genotype/Phenotype Correlations in Primary Hyperoxaluria." These patients have already consented for their samples to be used in genetic research and that consent will serve to enroll them in this study, OR
5. Patients previously enrolled in the Rare Kidney Stone Consortium 6403 protocol (identified as legacy samples), "Screening for Dent Disease Mutations in Patients with Proteinuria or Hypercalciuria and Calcium Urolithiasis." These patients have already consented for their samples to be used in genetic research and that consent will serve to enroll them in this study, OR
6. Family member of a patient that meets at least one of the above criteria

2. Unwilling or unable to provide consent/assent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David J. Sas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Sas, DO

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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RKSC Study Coordinators

Role: CONTACT

800-270-4637

Facility Contacts

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RKSC Study Coordinators

Role: primary

800-270-4637

Related Links

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http://www.rarekidneystones.org

Rare Kidney Stone Consortium

Other Identifiers

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U54DK083908

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-005513

Identifier Type: -

Identifier Source: org_study_id

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