Clinical trial NCT00875823: International Registry for Primary Hyperoxaluria
Official title: International Registry for Hereditary Calcium Stone Diseases
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Primary Hyperoxaluria
Nephrocalcinosis
Kidney Stones
Keywords: PH
Primary Hyperoxaluria
Type I
Type II
NonI-NonII
Kidney stones
oxalate
oxalosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Oxalosis and Hyperoxaluria Foundation (OHF)
First posted: 2009-04-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with a confirmed diagnosis of primary hyperoxaluria (PH)

Brief summary: The purpose of this study is to collect medical information from a large number of patients in many areas of the world with primary hyperoxaluria. This medical information will be entered into a registry to help the investigators compare similarities and differences in patients and their symptoms. The more patients that the investigators are able to enter into the registry, the more the investigators will be able to understand primary hyperoxaluria and learn better ways of treating patients with this disease. It is the investigators hope that by entering as many patients with PH as possible, the information that the investigators collect may help physicians diagnose patients sooner and determine what treatments may work best on patients with similar medical or genetic backgrounds.

Detailed description: This study involves the collection of medical information to create a computer database (registry) for patients with PH. The information will be entered into the registry by your physician, healthcare provider or a staff member of the Mayo Clinic Hyperoxaluria Center. The computer web site for the registry is secure and protected by a required password. Some information which will be entered may include your age at first symptoms of PH,kidney stone history, lab values, kidney function, and your health over time. Information for a patient can only be viewed by the appropriate physician and staff. Once the information is entered into the registry, you will only be identified by a code number.

Eligibility criteria: Inclusion Criteria:

* Liver biopsy or genetic analysis that confirms a diagnosis of hyperoxaluria
* In the absence of a liver biopsy:
* Urine oxalate excretion of \>0.8 mmol/1.73 m² /day without other causes such as enteric hyperoxaluria
* Family history of PH in a sibling will be supportive
* A history or current finding of kidney stones or nephrocalcinosis will be supportive
* An increase in urine glycolate may suggest PHI or an increase in urine L-glycerate may suggest PHII, though not required for diagnosis.
* Patients presenting in renal failure with an elevate pre-dialysis plasma oxalate of 60 umol/l and a kidney biopsy that confirms extensive oxalate deposition, or evidence of systemic oxalosis

Exclusion Criteria:

* Patients without any of the above or a confirmed diagnosis of PH

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Children's Hospital at UCLA
state: California
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic Department of Nephrology and Hypertension
name: John C Lieske, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lieske JC, Monico CG, Holmes WS, Bergstralh EJ, Slezak JM, Rohlinger AL, Olson JB, Milliner DS. International registry for primary hyperoxaluria. Am J Nephrol. 2005 May-Jun;25(3):290-6. doi: 10.1159/000086360. Epub 2005 Jun 15.