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

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ClinicalTrials.gov Identifier: NCT05200871
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Travere Therapeutics, Inc.

Study Description
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Brief 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).

Condition or disease
Focal Segmental Glomerulosclerosis Immunoglobulin A Nephropathy

Study Design
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Study Type : Observational
Estimated Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official 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
Actual Study Start Date : February 5, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200871


Contacts
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Contact: Nisha Hazra, PhD +44 (0) 20 3480 7900 nisha.hazra@analysisgroup.com
Contact: Jenny Zhou, PhD +44 (0) 20 3480 7900 jenny.zhou@analysisgroup.com

Locations
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United States, California
Travere Investigational Site Recruiting
San Francisco, California, United States, 94115
United States, New Jersey
Travere Investigational Site Recruiting
Belmar, New Jersey, United States, 07719
United States, North Carolina
Travere Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Travere Investigational Site Recruiting
King Of Prussia, Pennsylvania, United States, 19406
Spain
Travere Investigational Site Recruiting
Madrid, Spain, 28002
Sponsors and Collaborators
Travere Therapeutics, Inc.
Investigators
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Study Director: Leah Conley, MBA Travere Therapeutics
More Information
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Responsible Party: Travere Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05200871    
Other Study ID Numbers: TVTX-RE021-402
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Travere Therapeutics, Inc.:
Observational
Cross-Sectional
Survey
Health-related quality of life (HRQoL)
 Patients
Care-Partners
Humanistic
Burden
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulosclerosis, Focal Segmental
Glomerulonephritis, IGA
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases