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Идёт набор NCT05505500

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

— Наблюдательное Fluid Overload Glomerulosclerosis, Focal Segmental Edema Membranous Nephropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Interview.
Кому может быть актуально
Состояния в реестре: Fluid Overload, Glomerulosclerosis, Focal Segmental, Edema, Membranous Nephropathy. Базовые параметры: от 2 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome

Обзор

Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome. Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.

Подробное описание

This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema/fluid overload of nephrotic syndrome. The measures to be developed include an Observer Reported Outcome (ObsRO) and Patient Reported Outcome (PRO). The ObsRO and PRO substudies are Institutional Review Board (IRB) approved at release.

The researcher's goal is to produce core outcome sets of patient-rated and observer reported Fluid Overload (edema) measures that can be applied across the fluid overload severity continuum, fit to help drug development in this area.

Вмешательства

  • Поведенческое Interview
    Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.

Первичные конечные точки

  • Patient Reported Impact of Fluid Overload on symptoms and functioning [Срок оценки: Interviews are 60 minutes]
  • Observer Reported Impact of Fluid Overload on symptoms and functioning [Срок оценки: Interviews are 60 minutes]

Критерии участия

Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:

Критерии включения

  • Parents/guardians must be able to read and understand English;
  • Parents/guardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;
  • The child must have a current NS-associated edema
  • The child must have native kidney function
  • Parents/guardians must provide informed consent.

Критерии исключения

1\. Index case with dialysis dependence throughout the 3-month pre-enrollment period

Criteria for the Patient Reported Outcomes (PRO) cohort of the study:

Критерии включения

  • ≥8 years of age
  • Able to read and understand English
  • Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.

i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied

  • Current NS-associated edema
  • Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) > 25 ml/min/1.73m2
  • Informed Consent: For patients ≥8 to <18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.

Критерии исключения

  • Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period
  • Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT05505500 · HUM00208148 · 5UG3FD007308-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗