International Registry for Primary Hyperoxaluria
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Purpose
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 |
|---|
|
Primary Hyperoxaluria Nephrocalcinosis Kidney Stones |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | International Registry for Hereditary Calcium Stone Diseases |
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
PH Patients
Patients with: Primary Hyperoxaluria Type I Primary Hyperoxaluria Type II Primary Hyperoxaluria NonI-NonII |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Any patient with a confirmed diagnosis of primary hyperoxaluria (PH)
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| United States, California | |
| Mattel Children's Hospital at UCLA | |
| Los Angeles, California, United States, 90095 | |
| University of California at Davis | |
| Sacramento, California, United States, 95817 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | John C Lieske, M.D. | Mayo Clinic Department of Nephrology and Hypertension |
More Information
Additional Information:
Publications:
| Responsible Party: | John C. Lieske, M.D., Mayo Clinic Department of Nephrology |
| ClinicalTrials.gov Identifier: | NCT00875823 History of Changes |
| Obsolete Identifiers: | NCT00616525 |
| Other Study ID Numbers: | 1605-03 |
| Study First Received: | April 2, 2009 |
| Last Updated: | December 2, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
PH Primary Hyperoxaluria Type I Type II |
NonI-NonII Kidney stones oxalate oxalosis |
Additional relevant MeSH terms:
|
Calculi Hyperoxaluria Hyperoxaluria, Primary Kidney Calculi Nephrolithiasis Nephrocalcinosis Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases |
Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Urolithiasis Urinary Calculi Calcinosis Calcium Metabolism Disorders |
ClinicalTrials.gov processed this record on May 22, 2013