Focal Segmental GlomerulosclerosisHONUSNCT05200871
Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
An observational study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, run by Travere Therapeutics, Inc. at 6 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy
- How many people
- 487 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 5 Feb 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Travere Investigational Site
Belmar, New Jersey, 07719
Travere Investigational Site
Chapel Hill, North Carolina, 27599
Travere Investigational Site
King of Prussia, Pennsylvania, 19406
Travere Investigational Site
San Francisco, California, 94115
About this study
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
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).
- Keywords
- Observational, Cross-Sectional, Survey, Health-related quality of life (HRQoL), Patients, Care-Partners, Humanistic, Burden
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Day 1, day of enrollment
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).
Measured: Day 1, day of enrollment
Adult patient, adult patient care-partner and pediatric patient parent/care-partner anxiety.
Measured by General Anxiety Disorder 7 (GAD-7) questionnaire.
Measured: Day 1, day of enrollment
Adult patient, adult patient care-partner and pediatric patient parent/care-partner depression.
Measured by Patient Health Questionnaire 9 (PHQ-9) module.
Measured: Day 1, day of enrollment
Adult patient cognition.
Measured by cognition items of the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire (CPFQ).
Measured: Day 1, day of enrollment
Adult patient symptoms.
Measured by 5-point Likert scale ranking of most burdensome symptoms.
Measured: Day 1, day of enrollment
Pediatric patient symptoms (reported by parent/care-partner).
Measured by 5-point Likert scale ranking of most burdensome symptoms.
Measured: 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.
Measured by 5-point Likert scale fear and anxiety for the future.
Measured: Day 1, day of enrollment
Adult patient productivity impairment.
Measured by Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).
Measured: Day 1, day of enrollment
Adult patient care-partner and pediatric patient parent/care-partner productivity impairment.
Measured by Work Productivity and Activity Impairment Questionnaire (WPAI) caregiver version.
Measured: Day 1, day of enrollment
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.
Measured: Day 1, day of enrollment
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.
Measured: Day 1, day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start5 Feb 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travere Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leah Conley, MBA, Study director, Travere Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200871
- Sponsor's protocol ID
- TVTX-RE021-402
- Acronym
- HONUS
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05200871
- Acronym / sponsor ID
- HONUS / TVTX-RE021-402
- Keywords
- Observational, Cross-Sectional, Survey, Health-related quality of life (HRQoL), Patients, Care-Partners, Humanistic, Burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Travere Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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).
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).
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).
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.
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.
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).
Adult patient symptoms.
Time frame: Day 1, day of enrollment
Measured by 5-point Likert scale ranking of most burdensome symptoms.
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.
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.
Adult patient productivity impairment.
Time frame: Day 1, day of enrollment
Measured by Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Conley, MBA study director
Travere Therapeutics
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Segmental Glomerulosclerosis and Immunoglobulin A Nephropathy, run by Travere Therapeutics, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: Day 1, day of enrollment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.