Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT01705132
Eligibility Criteria:
Inclusion Criteria:
Subjects eligible for inclusion in this study have to fulfill all of the following criteria:
1. Able to understand and comply with the requirements of the study and able to provide written informed consent.
2. Male and female subjects ≥ 5 years of age.
3. Physically able to provide a single first-morning urine sample of at least 30 mL (one ounce).
4. Alport syndrome diagnosis: Clinical and/or histopathologic and/or genetic diagnosis of Alport Syndrome, as per the subject's physician and/or genotyping.
Exclusion Criteria:
Subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
2. Chronic kidney disease, defined as a known diagnosis of CKD, and/or receiving chronic phosphate-lowering therapy or erythropoietin therapy.
3. Ongoing chronic hemodialysis therapy and/or renal transplant recipient.
4. Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
65 Years
Study:
NCT01705132
Study Brief:
Protocol Section:
NCT01705132