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

February 20, 2024 updated by: Travere Therapeutics, Inc.

Humanistic Burden of Rare Kidney Diseases: Understanding the Impact of FSGS and IgAN on Patients and Caregivers Study (HONUS) - A Multi-National, Cross-Sectional Survey Study

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

487

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Villingen-Schwenningen, Germany
        • Travere Investigational Site
  • Spain
      • Madrid, Spain, 28002
        • Travere Investigational Site
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Travere Investigational Site
    • New Jersey
      • Belmar, New Jersey, United States, 07719
        • Travere Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Travere Investigational Site
    • Pennsylvania
      • King Of Prussia, Pennsylvania, United States, 19406
        • Travere Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult patients with FSGS or IgAN and their adult care-partners, as well as parents/care-partners of children/adolescents with FSGS or IgAN, who meet specified inclusion/exclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Adult patients
Adult patients (at least 18 years old) with FSGS or IgAN located in each of the six countries
Adult patient care-partners of adult patients
Adult care-partners (paired with adult patients) (at least 18 years old) of adult patients with FSGS or IgAN located in each of the six countries
Adult patient care-partners of pediatric/adolescent patients
Adult parents/care-partners (paired with adult patients) (at least 18 years old) of pediatric/ adolescent patients with FSGS or IgAN located in each of the six countries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Day 1, day of enrollment

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
Disease history.
Time Frame: Day 1, day of enrollment

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Travere Therapeutics, Inc.

Investigators

  • Study Director: Leah Conley, MBA, Travere Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2022

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVTX-RE021-402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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