NCT05200871

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

November 22, 2021

Last Update Submit

February 20, 2024

Conditions

Focal Segmental GlomerulosclerosisImmunoglobulin A Nephropathy

Keywords

ObservationalCross-SectionalSurveyHealth-related quality of life (HRQoL)PatientsCare-PartnersHumanisticBurden

Outcome Measures

Primary Outcomes (15)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Adult patient cognition.

    Measured by cognition items of the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire (CPFQ).

    Day 1, day of enrollment

  • Adult patient symptoms.

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

    Day 1, day of enrollment

  • Pediatric patient symptoms (reported by parent/care-partner).

    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.

    Measured by 5-point Likert scale fear and anxiety for the future.

    Day 1, day of enrollment

  • Adult patient productivity impairment.

    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.

    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.

    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).

    Measured by 5-point Likert scale impact on patient education, career (adolescents), employment (adolescents), relationships and lifestyle.

    Day 1, day of enrollment

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Travere Investigational Site

San Francisco, California, 94115, United States

Location

Travere Investigational Site

Belmar, New Jersey, 07719, United States

Location

Travere Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

Travere Investigational Site

King of Prussia, Pennsylvania, 19406, United States

Location

Travere Investigational Site

Villingen-Schwenningen, Germany

Location

Travere Investigational Site

Madrid, 28002, Spain

Location

MeSH Terms

Conditions

Glomerulosclerosis, Focal SegmentalGlomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Leah Conley, MBA

    Travere Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

January 21, 2022

Study Start

February 5, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

DE(1)ES(1)US(4)