International Registry for Primary Hyperoxaluria

NCT00875823 | Withdrawn DMC

• 1 other identifier: 1605-03
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Primary Hyperoxaluria; Nephrocalcinosis; Kidney Stones

Keywords

PH; Primary Hyperoxaluria; Type I; Type II; NonI-NonII; Kidney stones; oxalate; oxalosis

Study Arms (1)

PH Patients

Patients with: Primary Hyperoxaluria Type I Primary Hyperoxaluria Type II Primary Hyperoxaluria NonI-NonII

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator
• Oxalosis and Hyperoxaluria Foundation (OHF): collaborator

Study Sites (4)

Mattel Children's Hospital at UCLA

Los Angeles, California, 90095, United States

Location

University of California at Davis

Sacramento, California, 95817, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 15961949 RESULT

Related Links

• Mayo Clinic Hyperoxaluria Center
• Oxalosis and Hyperoxaluria Foundation

MeSH Terms

Conditions

Hyperoxaluria, Primary; Nephrocalcinosis; Kidney Calculi; Hyperoxaluria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcinosis; Calcium Metabolism Disorders; Nephrolithiasis; Urolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• John C Lieske, M.D.

  Mayo Clinic Department of Nephrology and Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: September 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (4)