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Идёт набор NCT07360938

Drug Interaction Potential of Pro-Inflammatory Conditions

— Наблюдательное Diabetes Mellitus, Type 2 End Stage Renal Disease Irritable Bowel Syndrome

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: None (Observational).
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 2, End Stage Renal Disease, Irritable Bowel Syndrome. Базовые параметры: 12 лет — 99 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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Обзор

Pro-inflammatory cytokines, which are elevated in pro-inflammatory disease states (e.g., type II diabetes mellitus \[T2DM\], irritable bowel diseases \[IBD\], and end stage renal disease \[ESRD\]) have been shown to inhibit hepatic drug-metabolizing enzymes, including members of the cytochrome P450 (CYP) family, and drug transporters; resultantly, pro-inflammatory diseases have been demonstrated to increase the exposure and potential for adverse drug events with co-administered CYP and drug transporter substrates. However, the clinical relevance of pro-inflammatory disease-drug interactions has not been systematically evaluated. The long-term goal of this research is to establish clinical strategies to mitigate pro-inflammatory disease-drug interactions and associated adverse drug events. The specific objective of this study is to determine the clinical relevance of pro-inflammatory disease-drug interactions, including establishment of the effect of pro-inflammatory diseases on drug disposition throughout disease trajectories (i.e., determining the differential effects on drug disposition based on the severity of disease). Towards this objective, this study will investigate the extent of increases in inflammation in patients with varying severities of pro-inflammatory diseases and estimate the resulting effects on drug disposition. Cytokine/chemokine concentrations and immune cell profiles will be assayed from blood samples of adult and pediatric patients with differing severities of pro-inflammatory diseases, using established disease monitoring parameters (e.g., glycosylated hemoglobin \[HbA1C\] for T2DM, C-reactive protein \[CRP\] for IBD, proteinuria for ESRD). The effect of changes in inflammation during differing severities of these pro-inflammatory diseases on drug disposition will then be estimated using established pharmacokinetic modeling approaches (e.g., physiologically-based pharmacokinetic modeling \[PBPK\]).

Вмешательства

  • Другое None (Observational)
    This observational study will not involve any interventions. Instead, the study will collect blood samples at one or multiple time points.

Первичные конечные точки

  • Quantification of Plasma Cytokine Concentrations [Срок оценки: Through study completion, up to 2 years post enrollment]
  • Phenotyping of Patient Immune Cells [Срок оценки: Through study completion, up to 2 years post enrollment]
  • Quantification of the Plasma Concentrations of Endogenous Biomarkers of Drug Metabolism and Transport [Срок оценки: Through study completion, up to 2 years post enrollment]
  • Measures of Inflammatory Disease Severity [Срок оценки: Through study completion, up to 2 years post enrollment]
  • Development of Adverse Events Attributable to CYP/Transporter Substrate Medications [Срок оценки: Through study completion, up to 2 years post enrollment]
Вторичные конечные точки (1)
  • Patient Genomic Markers [Срок оценки: Through study completion, up to 2 years post enrollment]

Критерии участия

Критерии включения

  • Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD
  • Ability to provide written informed consent and HIPAA authorization

Критерии исключения

  • Diagnosis or past medical history of non-IBD autoimmune disorder, including systemic lupus erythematosus, Sjogren's syndrome, multiple sclerosis, type 1 diabetes mellitus, Behcet's disease, and ankylosing spondylitis
  • Current infection requiring medical treatment (note: if a prospective patient's infection resolves, they can be re-screened for trial inclusion)
  • Concomitant treatment with systemic immunosuppressant drugs

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
  • Indiana University Hospital — Indianapolis

Идентификаторы

NCT: NCT07360938 · 27983

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗