Alport Syndrome Treatments and Outcomes Registry (ASTOR)
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00481130 |
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Recruitment Status :
Recruiting
First Posted : June 1, 2007
Last Update Posted : April 7, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | May 30, 2007 | ||||||||
| First Posted Date | June 1, 2007 | ||||||||
| Last Update Posted Date | April 7, 2023 | ||||||||
| Study Start Date | September 2007 | ||||||||
| Estimated Primary Completion Date | January 2030 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Data Collection: natural history study [ Time Frame: Ongoing ] | ||||||||
| 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 | Alport Syndrome Treatments and Outcomes Registry | ||||||||
| Official Title | Alport Syndrome Treatments and Outcomes Registry | ||||||||
| Brief Summary | ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport syndrome. ASTOR also aims to provide patients, families and physicians with the most up-to-date information about Alport syndrome. | ||||||||
| Detailed Description | The University of Minnesota's Department of Pediatrics has created the Alport Syndrome Treatments and Outcomes Registry (ASTOR). ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport syndrome. ASTOR also aims to provide patients, families and physicians with the most up-to-date information about Alport syndrome. You can help doctors learn more about Alport syndrome and test possible treatments for the disease by enrolling in ASTOR. Since Alport syndrome is a rare disease it is essential for ASTOR to enroll as many patients as possible. Together, you and others facing the challenges of Alport syndrome can provide valuable information that will help doctors better understand the disease and in turn, help patients with Alport syndrome now and in the future. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Family-Based Time Perspective: Other |
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| Target Follow-Up Duration | 15 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Family and individual history of a diagnosis of Alport syndrome | ||||||||
| Condition | Alport Syndrome | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults-an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-719. doi: 10.1007/s00467-020-04819-6. Epub 2020 Nov 6. Erratum In: Pediatr Nephrol. 2021 Jan 12;: | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment |
500 | ||||||||
| Estimated Study Completion Date | January 2030 | ||||||||
| Estimated Primary Completion Date | January 2030 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria: History of a diagnosis of Alport syndrome, Family or individuals need to be able to comprehend the consent and HIPAA forms written in the English language. Exclusion Criteria: Uncertain diagnosis of Alport syndrome. |
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| Sex/Gender |
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| Ages | 0 Years to 99 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT00481130 | ||||||||
| Other Study ID Numbers | 0704M05941 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | University of Minnesota | ||||||||
| Original Responsible Party | Not Provided | ||||||||
| Current Study Sponsor | University of Minnesota | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University of Minnesota | ||||||||
| Verification Date | April 2023 | ||||||||