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Completed

NCT Number: NCT05200871

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

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).

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Key information

Conditions

Focal Segmental Glomerulosclerosis Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Glomerulosclerosis, Focal Segmental Immune System Diseases Immunoglobulin A Nephropathy Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Travere Investigational Site, Villingen-Schwenningen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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).

  9. Adult patient symptoms.

    Time frame: Day 1, day of enrollment

    Measured by 5-point Likert scale ranking of most burdensome symptoms.

  10. 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.

  11. 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.

  12. Adult patient productivity impairment.

    Time frame: Day 1, day of enrollment

    Measured by Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Travere Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: HONUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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