Vessel wall inflammation
Conditions
Interventions
Product Name: Nanocort
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Nanocort
CAS Number: 125-02-0
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Concentration unit
Sponsors
AMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: 1) Patients who are scheduled for endarterectomy due to peripheral artery disease. 2) If using a statin, on stable therapy for at least 6 weeks prior to screening with no evidence of statin intolerance. 3) For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to baseline measurement. 4) For patients taking Nonsteroidal anti-inflammatory drugs (NSAIDS), Cyclo-oxygenase-2 inhibitors (COXIBs), use of a stable dose for at least 6 weeks prior to baseline measurement. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Subjects may not enter this study if they meet the following criteria: 1) Current medical history of Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy. 2) Recent or current treatment with medications that may have a significant effect on plaque inflammation, including but not limited to: • Steroids for at least 6 weeks prior to baseline measurement and during study (with the exception of inhaled steroids). • Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex. Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and during the study • No other Disease modifying antirheumatic drugs (DMRADS) within 6 weeks of baseline and during study (such as cyclosporine, azatioprine, etc.) 3) Known systemic disorder, such as hepatic, renal, hematologic or endocrine diseases, infections or malignancies, or any clinically significant medical condition that could interfere with the conduct of the study. 4) Subjects with a known ulcus ventriculi or duodeni. 5) Female subjects who are breastfeeding, pregnant or trying to get pregnant. 6) History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses. 7) History of hypersensitivity to methylprednisolone or any component of the formulation. 8) Any history of myopathy or a history of neuromuscular disorders (e.s, myasthenia gravis). 9) Any planned vaccinations. 10) Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. 11) Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment. Subjects scheduled for endarterectomy are not excluded. 12) Current medical history of drug or alcohol abuse within 12 months prior to screening. 13) Subjects are not permitted to enter the study if they have taken any investigational drug in the 3 months prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To proof local delivery of intravenously administered liposomal glucocorticoids (Nanocort) in subjects with peripheral artery disease by demonstrating Nanocort in atherosclerotic tissue. ;Timepoint(s) of evaluation of this end point: Infusion period between day -10 to day -3, before scheduled endarterectomy. ;Secondary Objective: To determine the differences between cytokine production of isolated atherosclerotic macrophages from patients with peripheral artery disease treated with liposomal glucocorticoids (Nanocort), systemic glucocorticoids (Methylprednisone) or placebo. To determine the differences between cytokine production of isolated atherosclerotic macrophages from patients with peripheral artery disease treated with liposomal glucocorticoids (Nanocort), systemic glucocorticoids (Methylprednisone) or placebo after an ex vivo Low dose LPS stimulation.;Primary end point(s): Quantity of PEG liposomes in the atherosclerotic plaque and/ or in atherosclerotic macrophages as determined with a PEG antibody quantitative sandwich ELISA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Differences between TNF-alpha levels in the supernatant of isolated macrophages from the atherosclerotic tissue as determined by quantitative sandwich ELISA ;Timepoint(s) of evaluation of this end point: Infusion period between day -10 to day -3, before scheduled endarterectomy. | — |
Countries
Netherlands
Contacts
Public ContactStroes
AMC
Outcome results
None listed