ASF Alport Patient Registry

NCT06526741 | Recruiting

• 1 other identifier: ASF-01
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Alport Syndrome Foundation's (ASF's) Alport Patient Registry (the Registry) is open to individuals living with Alport syndrome in the United States (US) and US territories and outlying islands. The Registry welcomes participants of all ages who have a confirmed clinical diagnosis of Alport syndrome. A confirmed diagnosis could be obtained via genetic testing, biopsy, and/or from a medical professional's clinical assessment of the individual's symptoms and/or family history. Participants can have any form and stage of this disease to be eligible for inclusion in the Registry. Patient participation in the Registry is crucial to helping attract and advance research, understanding understudied aspects of the disease, and informing clinical trials that may lead to Alport syndrome therapies and/or a cure. The Registry is accessed through a secure, online application. Participants report their own health history in the Registry and are encouraged to update any changes, at most, every three months. The security of each participant's information is a top priority. Any detail that could identify an individual participant is kept confidential in the Registry and such data are de-identified to protect the participant's privacy. No electronic health records or social security numbers are requested by or connected to the Registry. A parent or legal guardian may consent to enroll a child/dren Alport patient(s) under the age of 18 years. An additional assent form is used for individuals ages 7-17. At age 18, participants will be required to re-consent as an adult if they choose to continue to participate in the Registry.

Conditions

Alport Syndrome; Thin Basement Membrane Disease; Hereditary Nephritis

Keywords

Alport; COL4A3; COL4A4; COL4A5; Collagen Type-IV; Glomerulonephropathy; Glomerulosclerosis; Genetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Total number of enrolled participants

  Reach 750 enrolled participants

  5 years

Study Arms (1)

Alport syndrome patients

Patients with a confirmed diagnosis of Alport syndrome by a certified genetic counselor, treating physician, or nephrologist.

Other: Longitudinal data collection

Interventions

Longitudinal data collection OTHER

This is an observational ambispective non-interventional registry collecting longitudinal real-world data only. There is no intervention.

Alport syndrome patients

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Alport syndrome patients

You may qualify if:

• Confirmed diagnosis of Alport syndrome by a certified genetic counselor, treating physician or nephrologist.
• Signed informed consent/assent must be provided by the subject and/or caregiver (parent/legal guardian) including compliance with the restrictions listed in the informed consent/assent form and in the study protocol. (Separate age-appropriate assent forms are provided for ages 7-12 years and ages 13-17 years.)
• Must reside in the USA or US territories and outlying islands. (This criterium may change at an as-yet undetermined future date.)

You may not qualify if:

• \[none\]

Sponsors & Collaborators

• Alport Syndrome Foundation: lead
• Pulse Infoframe Inc: collaborator

Study Sites (1)

On-line only: https://asfalportpatientregistry.healthie.net

Scottsdale, Arizona, 85261, United States

RECRUITING

Related Links

• ASF Alport Patient Registry new registration link
• ASF Alport Patient Registry returning participant/legal guardian login
• Alport Syndrome Foundation (sponsor)
• Pulse Infoframe Inc. (partner \& host)
• North Star Review Board (independent review board)

MeSH Terms

Conditions

Nephritis, Hereditary; Hematuria, Benign Familial

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Makabe Aberle, BS

  Alport Syndrome Foundation

  PRINCIPAL INVESTIGATOR

• Bradley Warady, MD

  Medical Advisory Committee, Alport Syndrome Foundation

  STUDY CHAIR

Central Study Contacts

Makabe Aberle, BS

CONTACT

4808003510; kaberle@alportsyndrome.org

Lisa Bonebrake, BS

CONTACT

6199873522; lbonebrake@alportsyndrome.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: July 30, 2024
• Study Start: August 24, 2023
• Primary Completion (Estimated): August 23, 2048
• Study Completion (Estimated): August 23, 2048
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)