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International Registry for Primary Hyperoxaluria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00875823
Recruitment Status : Withdrawn (Study was combined with Mayo protocol 07-003476)
First Posted : April 3, 2009
Last Update Posted : April 7, 2015
National Institutes of Health (NIH)
Oxalosis and Hyperoxaluria Foundation (OHF)
Information provided by:
Mayo Clinic

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
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.

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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 : September 2003
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

PH Patients

Patients with:

Primary Hyperoxaluria Type I Primary Hyperoxaluria Type II Primary Hyperoxaluria NonI-NonII

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875823

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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
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Oxalosis and Hyperoxaluria Foundation (OHF)
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Principal Investigator: John C Lieske, M.D. Mayo Clinic Department of Nephrology and Hypertension
Additional Information:
Publications of Results:
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Responsible Party: John C. Lieske, M.D., Mayo Clinic Department of Nephrology Identifier: NCT00875823    
Obsolete Identifiers: NCT00616525
Other Study ID Numbers: 1605-03
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Mayo Clinic:
Primary Hyperoxaluria
Type I
Type II
Kidney stones
Additional relevant MeSH terms:
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Kidney Calculi
Hyperoxaluria, Primary
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Calcium Metabolism Disorders