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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.
 
ClinicalTrials.gov Identifier: NCT00875823
Recruitment Status : Withdrawn (Study was combined with Mayo protocol 07-003476)
First Posted : April 3, 2009
Last Update Posted : April 7, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Oxalosis and Hyperoxaluria Foundation (OHF)
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date April 2, 2009
First Posted Date April 3, 2009
Last Update Posted Date April 7, 2015
Study Start Date September 2003
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Registry for Primary Hyperoxaluria
Official Title International Registry for Hereditary Calcium Stone Diseases
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any patient with a confirmed diagnosis of primary hyperoxaluria (PH)
Condition
  • Primary Hyperoxaluria
  • Nephrocalcinosis
  • Kidney Stones
Intervention Not Provided
Study Groups/Cohorts PH Patients

Patients with:

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

Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 6, 2015)
0
Original Estimated Enrollment
 (submitted: April 2, 2009)
400
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00875823
Other Study ID Numbers 1605-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John C. Lieske, M.D., Mayo Clinic Department of Nephrology
Study Sponsor Mayo Clinic
Collaborators
  • National Institutes of Health (NIH)
  • Oxalosis and Hyperoxaluria Foundation (OHF)
Investigators
Principal Investigator: John C Lieske, M.D. Mayo Clinic Department of Nephrology and Hypertension
PRS Account Mayo Clinic
Verification Date April 2015