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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00875823
Other study ID # 1605-03
Secondary ID
Status Withdrawn
Phase N/A
First received April 2, 2009
Last updated April 6, 2015
Start date September 2003
Est. completion date July 2009

Study information

Verified date April 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00616525

Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
United States Children's Memorial Hospital Chicago Illinois
United States Mattel Children's Hospital at UCLA Los Angeles California
United States Mayo Clinic Rochester Rochester Minnesota
United States University of California at Davis Sacramento California

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic National Institutes of Health (NIH), Oxalosis and Hyperoxaluria Foundation (OHF)

Country where clinical trial is conducted

United States, 

References & 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. Epub 2005 Jun 15. — View Citation

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