Primary HyperoxaluriaNCT00875823
International Registry for Primary Hyperoxaluria
An observational study of Primary Hyperoxaluria and Nephrocalcinosis, run by Mayo Clinic at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Hyperoxaluria, Nephrocalcinosis, Kidney Stones
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2003to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient with a confirmed diagnosis of primary hyperoxaluria (PH)
Who may be able to join
- 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
Who cannot join
- Patients without any of the above or a confirmed diagnosis of PH
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Memorial Hospital
Chicago, Illinois, 60614
Mattel Children's Hospital at UCLA
Los Angeles, California, 90095
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California at Davis
Sacramento, California, 95817
About this study
Official title: International Registry for Hereditary Calcium Stone Diseases
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.
Read the 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.
- Conditions
- Primary Hyperoxaluria, Nephrocalcinosis, Kidney Stones
- Keywords
- PH, Primary Hyperoxaluria, Type I, Type II, NonI-NonII, Kidney stones, oxalate, oxalosis
- Medical subject headings
- Hyperoxaluria, Primary, Nephrocalcinosis, Kidney Calculi, Hyperoxaluria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PH Patients | Patients with: Primary Hyperoxaluria Type I Primary Hyperoxaluria Type II Primary Hyperoxaluria NonI-NonII |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startSep 2003
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Study was combined with Mayo protocol 07-003476
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperoxaluriaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Oxalosis and Hyperoxaluria Foundation (OHF)
- Investigators
- John C Lieske, M.D., Principal investigator, Mayo Clinic Department of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875823
- Sponsor's protocol ID
- 1605-03
- Status last verified
- Apr 2015
- First submitted
- 2 Apr 2009
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1159/000086360. Epub 2005 Jun 15.
PubMed 15961949
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry for Hereditary Calcium Stone Diseases
- ClinicalTrials.gov ID
- NCT00875823
- Acronym / sponsor ID
- 1605-03
- Conditions
- Primary Hyperoxaluria, Nephrocalcinosis, Kidney Stones
- Keywords
- PH, Primary Hyperoxaluria, Type I, Type II, NonI-NonII, Kidney stones, oxalate, oxalosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was combined with Mayo protocol 07-003476
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Oxalosis and Hyperoxaluria Foundation (OHF)
- Study start
- Sep 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PH Patients | – | –Patients with: Primary Hyperoxaluria Type I Primary Hyperoxaluria Type II Primary Hyperoxaluria NonI-NonII |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with a confirmed diagnosis of primary hyperoxaluria (PH)
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients without any of the above or a confirmed diagnosis of PH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 15961949Lieske 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.
- Oxalosis and Hyperoxaluria FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Lieske, M.D. principal investigator
Mayo Clinic Department of Nephrology and Hypertension
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperoxaluria and Nephrocalcinosis, run by Mayo Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00875823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.