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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05200871
Other study ID # TVTX-RE021-402
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2022
Est. completion date October 31, 2023

Study information

Verified date February 2024
Source Travere Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 487
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Travere Investigational Site Villingen-Schwenningen
Spain Travere Investigational Site Madrid
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 Travere Investigational Site San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Travere Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Day 1, day of enrollment
Primary 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.
Day 1, day of enrollment
Primary Adult patient health-related quality of life. Measured by Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36). Day 1, day of enrollment
Primary 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). Day 1, day of enrollment
Primary Adult patient care-partner and pediatric patient parent/care-partner health-related quality of life. Measured by 12-Item Short Form Health Survey (SF-12). Day 1, day of enrollment
Primary Adult patient, adult patient care-partner and pediatric patient parent/care-partner anxiety. Measured by General Anxiety Disorder 7 (GAD-7) questionnaire. Day 1, day of enrollment
Primary Adult patient, adult patient care-partner and pediatric patient parent/care-partner depression. Measured by Patient Health Questionnaire 9 (PHQ-9) module. Day 1, day of enrollment
Primary Adult patient cognition. Measured by cognition items of the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire (CPFQ). Day 1, day of enrollment
Primary Adult patient symptoms. Measured by 5-point Likert scale ranking of most burdensome symptoms. Day 1, day of enrollment
Primary Pediatric patient symptoms (reported by parent/care-partner). Measured by 5-point Likert scale ranking of most burdensome symptoms. Day 1, day of enrollment
Primary Adult patient, pediatric patient (reported by parent/care-partner), adult patient care-partner and pediatric patient parent/care-partner fear and anxiety for the future. Measured by 5-point Likert scale fear and anxiety for the future. Day 1, day of enrollment
Primary Adult patient productivity impairment. Measured by Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP). Day 1, day of enrollment
Primary Adult patient care-partner and pediatric patient parent/care-partner productivity impairment. Measured by Work Productivity and Activity Impairment Questionnaire (WPAI) caregiver version. Day 1, day of enrollment
Primary Adult patient, adult patient care-partner and pediatric patient parent/care-partner impact of disease. Measured by and 5-point Likert scale impact on education, career, employment, relationships, personal finances and lifestyle. Day 1, day of enrollment
Primary Pediatric/adolescent patient impact of disease (reported by parent/care-partner). Measured by 5-point Likert scale impact on patient education, career (adolescents), employment (adolescents), relationships and lifestyle. Day 1, day of enrollment
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