Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)

N/ACompletedNCT05200871

Travere Therapeutics, Inc.487 enrolled

Overview

The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries (United States \[US\], United Kingdom \[UK\], France, Germany, Italy and Spain).

Study Type

OBSERVATIONAL

Enrollment

487

Conditions

Focal Segmental Glomerulosclerosis Immunoglobulin A Nephropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients and their adult care-partners: At least 18 years old; Either have a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis) or being a care-partner for someone with a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis); * Able to provide informed consent; * Located in the United States (US), United Kingdom (UK), Germany, France, Spain or Italy. \*Care-partners (paired with adult patients) (defined as the individual \[e.g., spouse, parent, sibling, relative, or friend\] providing direct disease-related support to the adult patient. \*\*All patient groups including chronic kidney disease (CKD) stage 1-5, with or without dialysis, and with or without kidney transplant will be included. * Care-partners/parents of children/adolescents: At least 18 years old; * Being a care-partner of children/adolescents with physician-provided diagnosis of FSGS or IgAN (with renal biopsy or genetic confirmation of the diagnosis); * Able to provide informed consent; Located in the US, UK, Germany, France, Spain or Italy. * Care-partners will be defined as family members who provide disease-related support and unpaid care to child/adolescent patients Exclusion Criteria: * Patient has FSGS or IgAN secondary to another condition; * Patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer; * Patient has a co-existing glomerular disease (e.g., membranous nephropathy, lupus nephritis); * Patient is currently participating in a kidney disease clinical trial, and potentially receiving active treatment as part of the trial.

Locations (6)

Travere Investigational Site

San Francisco, California, United States

Travere Investigational Site

Belmar, New Jersey, United States

Travere Investigational Site

Chapel Hill, North Carolina, United States

Travere Investigational Site

King of Prussia, Pennsylvania, United States

Outcomes

Primary Outcomes

Demographics

Adult patients (self-reported) - age, sex, education level, household income, marital status, current work status, race/ethnicity (for patients in the US and in the UK), health insurance (for patients in the US), approximate travel time to receive FSGS/IgAN medical care. Child/adolescent patients (reported by parent/care-partner) - age, sex, current school status, race/ethnicity (for patients in the US and in the UK), approximate travel time to receive FSGS/IgAN medical care. Care-partners of adult patients and parents/care-partners of child/adolescent patients - age, sex, education level, household income, marital status, relationship to person with FSGS/IgAN, current work status, race/ethnicity (for patients in the US and UK).

Time frame: Day 1, day of enrollment

Disease history.

Adult patients (self-reported) - length of time from onset of symptoms to diagnosis, time since diagnosis, renal biopsy status, comorbidities, CKD (Chronic kidney disease) stage at diagnosis, current CKD stage (including dialysis status), transplant status (including type of transplant and occurrence of rejection or recurrence of disease), current level of proteinuria. Pediatric/adolescent patients (reported by parent/care-partner) - length of time from onset of symptoms to diagnosis, time since diagnosis, renal biopsy status, comorbidities, CKD stage at diagnosis, current CKD stage (including dialysis status), transplant status (including type of transplant and occurrence of rejection or recurrence of disease), current level of proteinuria.

Time frame: Day 1, day of enrollment

Adult patient health-related quality of life.

Measured by Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36).

Time frame: Day 1, day of enrollment

Pediatric patient health-related quality of life (reported by parent/care-partner).

Measured by Pediatric Quality of Life Inventory (PedsQL) Parent report for teens (ages 13-18) or Parent report for children (ages 8-12).

Time frame: Day 1, day of enrollment

Data from ClinicalTrials.gov

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