Drug Interaction Potential of Pro-Inflammatory Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: None (Observational).
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, End Stage Renal Disease, Irritable Bowel Syndrome. Basic parameters: 12 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 \[PBPK\]).
Interventions
- Other None (Observational)
This observational study will not involve any interventions. Instead, the study will collect blood samples at one or multiple time points.
Primary outcome measures
- Quantification of Plasma Cytokine Concentrations [Time frame: Through study completion, up to 2 years post enrollment]
- Phenotyping of Patient Immune Cells [Time frame: Through study completion, up to 2 years post enrollment]
- Quantification of the Plasma Concentrations of Endogenous Biomarkers of Drug Metabolism and Transport [Time frame: Through study completion, up to 2 years post enrollment]
- Measures of Inflammatory Disease Severity [Time frame: Through study completion, up to 2 years post enrollment]
- Development of Adverse Events Attributable to CYP/Transporter Substrate Medications [Time frame: Through study completion, up to 2 years post enrollment]
Secondary outcome measures (1)
- Patient Genomic Markers [Time frame: Through study completion, up to 2 years post enrollment]
Eligibility criteria
Inclusion criteria
- Diagnosed with a pro-inflammatory disease, including T2DM, IBD, and ESRD
- Ability to provide written informed consent and HIPAA authorization
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Indiana University Hospital — Indianapolis
Identifiers
NCT: NCT07360938 · 27983