Alport SyndromeMANCT00622544
A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
An observational study of Alport Syndrome and Kidney Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather information about critical clinical time points such as when patients with small amounts of protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria). Read more about this study
- Who is it for?
- Ages Up to 18 years, men only
- Conditions the study is for
- Alport Syndrome, Kidney Disease
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: The study population is comprised of approximately 30 males ranging in age from 0 - 18 at the time of enrollment.
Who may be able to join
- Diagnosis of Alport syndrome, confirmed by skin biopsy, kidney biopsy, or molecular genetic analysis
- Diagnosis of Alport syndrome, based on presence of hematuria and confirmed diagnosis of Alport syndrome in a first-degree relative
- Male gender
- Absence of overt proteinuria, defined as urine protein:creatinine ratio less than 0.2 mg/mg
- Subject is not currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Who cannot join
- Female gender
- Presence of overt proteinuria
- Current treatment with ACEI or ARB
- End-stage kidney disease (on dialysis or kidney transplant recipient)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather information about critical clinical time points such as when patients with small amounts of protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria). Large amounts of protein in the urine is often an early sign of kidney disease.
Information needs to be collected in boys who are not taking medications known as angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain accurate data about the length of time between the onset of microalbuminuria and the start of overt proteinuria. This new information will give physicians a better understanding of how to treat patients with Alport syndrome.
Read more
The information we gather by conducting this study will aid in planning future clinical trials because the identification of time points in disease progression, such as microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical benefit of a new treatment option.
The study has been approved by the University of Minnesota's Institutional Review Board.
Read the detailed description
Study Aims
- To determine the average ages of onset of microalbuminuria and overt proteinuria in untreated boys with Alport syndrome
- To determine the average duration of microalbuminuria before transition to overt proteinuria in untreated boys with Alport syndrome
This study does not involve treatment and is anticipated to last 3-5 years.
- Conditions
- Alport Syndrome, Kidney Disease
- Keywords
- Microalbuminuria, Proteinuria
- Medical subject headings
- Nephritis, Hereditary, Kidney Diseases, Proteinuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Developing Microalbuminuria During Study Period
number of subjects developing microalbuminuria during study period
Measured: 2007-2009
Secondary outcomes (1)
Number of Subjects Developing Proteinuria During the Study Period
number of subjects developing proteinuria during the study period
Measured: 2007-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alport SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Clifford E Kashtan, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622544
- Sponsor's protocol ID
- 0707M11722
- Acronym
- MA
- Status last verified
- Sep 2017
- First submitted
- 13 Feb 2008
- Last updated
- 20 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
- ClinicalTrials.gov ID
- NCT00622544
- Acronym / sponsor ID
- MA / 0707M11722
- Conditions
- Alport Syndrome, Kidney Disease
- Keywords
- Microalbuminuria, Proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- Jul 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Posted 20 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the Microalbuminuria in Untreated Boys with Alport Syndrome study is to gather information about critical clinical time points such as when patients with small amounts of protein (microalbuminuria) in their urine progress to larger amounts (overt proteinuria). Large amounts of protein in the urine is often an early sign of kidney disease.
Information needs to be collected in boys who are not taking medications known as angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in order to obtain accurate data about the length of time between the onset of microalbuminuria and the start of overt proteinuria. This new information will give physicians a better understanding of how to treat patients with Alport syndrome.
The information we gather by conducting this study will aid in planning future clinical trials because the identification of time points in disease progression, such as microalbuminuria and overt proteinuria, could reduce the time necessary to show a clinical benefit of a new treatment option.
The study has been approved by the University of Minnesota's Institutional Review Board.
Detailed description
Study Aims
- To determine the average ages of onset of microalbuminuria and overt proteinuria in untreated boys with Alport syndrome
- To determine the average duration of microalbuminuria before transition to overt proteinuria in untreated boys with Alport syndrome
This study does not involve treatment and is anticipated to last 3-5 years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population is comprised of approximately 30 males ranging in age from 0 - 18 at the time of enrollment.
Key inclusion criteria (5 listed)
- Diagnosis of Alport syndrome, confirmed by skin biopsy, kidney biopsy, or molecular genetic analysis
- Diagnosis of Alport syndrome, based on presence of hematuria and confirmed diagnosis of Alport syndrome in a first-degree relative
- Male gender
- Absence of overt proteinuria, defined as urine protein:creatinine ratio less than 0.2 mg/mg
- Subject is not currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Key exclusion criteria (4 listed)
- Female gender
- Presence of overt proteinuria
- Current treatment with ACEI or ARB
- End-stage kidney disease (on dialysis or kidney transplant recipient)
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
Number of Subjects Developing Microalbuminuria During Study Period
Time frame: 2007-2009
number of subjects developing microalbuminuria during study period
1 secondary outcome
Number of Subjects Developing Proteinuria During the Study Period
Time frame: 2007-2009
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clifford E Kashtan, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alport Syndrome and Kidney Disease, run by University of Minnesota at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Subjects Developing Microalbuminuria During Study Period (time frame: 2007-2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2018.