International Registry for Primary Hyperoxaluria

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00875823

Collaborator

National Institutes of Health (NIH) (NIH), Oxalosis and Hyperoxaluria Foundation (OHF) (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperoxaluria Nephrocalcinosis Kidney Stones

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

International Registry for Hereditary Calcium Stone Diseases

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
PH Patients Patients with: Primary Hyperoxaluria Type I Primary Hyperoxaluria Type II Primary Hyperoxaluria NonI-NonII

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mattel Children's Hospital at UCLA	Los Angeles	California	United States	90095
2	University of California at Davis	Sacramento	California	United States	95817
3	Children's Memorial Hospital	Chicago	Illinois	United States	60614
4	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905