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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-05

Study Completion Date

2023-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Focal Segmental Glomerulosclerosis Immunoglobulin A Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adult patients

Adult patients (at least 18 years old) with FSGS or IgAN located in each of the six countries

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No