Primary Hyperoxaluria Clinical Trial
Official title:
Genetic Characterization and Genotype/Phenotype Correlations in Primary Hyperoxaluria
NCT number | NCT02340689 |
Other study ID # | 13-006384 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | December 2018 |
Verified date | August 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Specific mutations relating to hyperoxaluria will be determined via DNA analysis by the Mayo RKSC research staff.
Status | Completed |
Enrollment | 1235 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Ages birth to 99 years in whom clinical information is available from medical records - Patients with a diagnosis of PH confirmed on previous genetic testing - Patients with clinical suspicion of primary hyperoxaluria (elevated urine oxalate of greater than 0.8 mmol/1.73 m2/day (>70 mg/1.73 m2/day), history of kidney stones, and/or nephrocalcinosis documented by medical history or imaging studies - First or second degree family members of a patient with primary hyperoxaluria Exclusion Criteria: - Stone formers who do not have confirmed PH and do not meet the inclusion criteria for clinical suspicion of primary hyperoxaluria - Unwilling or unable to provide consent/assent. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Genotype markers of early symptomatic onset of primary hyperoxaluria | Correlation of genotype with severity of disease as defined by age at onset of symptoms | 5 years | |
Secondary | Genotype markers of marked hyperoxaluria in patients with primary hyperoxaluria | Correlation of genotype with severity of disease as defined by the level of urine oxalate | 5 years | |
Secondary | Genotype markers of early loss of kidney function in patients with primary hyperoxaluria. | Correlation of genotype with age at kidney failure | 5 years |
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