International Registry for Primary Hyperoxaluria

This study has been withdrawn prior to enrollment.
(Study was combined with Mayo protocol 07-003476)
Sponsor:
Collaborators:
Oxalosis and Hyperoxaluria Foundation (OHF)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00875823
First received: April 2, 2009
Last updated: December 2, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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
Study Population

Any patient with a confirmed diagnosis of primary hyperoxaluria (PH)

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875823

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
Sponsors and Collaborators
Mayo Clinic
Oxalosis and Hyperoxaluria Foundation (OHF)
Investigators
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:
Hyperoxaluria, Primary
Kidney Calculi
Nephrocalcinosis
Nephrolithiasis
Calcinosis
Calcium Metabolism Disorders
Calculi
Carbohydrate Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperoxaluria
Kidney Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014