NCT06051565CompletedPhase 1
Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Contrast-enhanced Cardiovascular Magnetic Resonance Imaging in Patients With Type 2 Diabetes and Chronic Kidney Disease.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country12 target enrollmentStarted: November 6, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Degree of vascular stenosis
Study Overview
Brief Summary
This is an open-label, single-center, single-dose study aims to evaluate the effect and safety of polymeric superparamagnetic iron oxide in cardiovascular magnetic resonance imaging for diabetic patients with concomitant chronic kidney disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged ≥ 18 years, ≤ 80 years.
- •Patients who have been diagnosed with chronic kidney disease (CKD) according to diagnostic criteria, meeting at least one CKD diagnostic criterion.
- •Patients with a confirmed history of atherosclerosis and/or chronic venous disease (including deep vein thrombosis, thrombotic venous inflammation, lower limb varicose veins, etc.) either in their medical history or diagnosed during hospital admission, and within the past year, at least one imaging examination has confirmed the presence of at least one of the following vascular abnormalities in at least one vascular bed:
- •≥50% vascular stenosis;
- •Arterial aneurysm;
- •Arterial dissection;
- •Arteriovenous malformation;
- •Arteriovenous fistula;
- •Vascular developmental abnormalities;
- •Varicose veins, etc. For details, please refer to the inclusion criteria section.
- •Patients capable of self-care in daily life.
- •Patients who voluntarily agree to participate in this study, sign an informed consent form, have a full understanding of the trial's content, procedures, and potential adverse reactions, and demonstrate good compliance.
- •Patients who are unwilling to sign an informed consent form for the exploratory research can still be enrolled in the main study.
- •Subjects who have no plans for pregnancy for at least 2 weeks before self-administration of the investigational drug and for at least 6 months after the last use of the investigational drug and voluntarily agree to adopt effective contraceptive measures.
Exclusion Criteria
- •Patients who have undergone stent implantation for vascular treatment in the target vascular bed.
- •Patients who have had or currently have malignant tumors within the last 3 years.
- •Serum ferritin > 1000 μg/L.
- •Patients who are planned to undergo magnetic resonance imaging (MRI) examination for various reasons during the trial.
- •Blood donation or significant blood loss (> 450 ml) within the two months before medication.
- •Patients with a history of substance abuse involving psychotropic drugs and are unable to quit or have psychiatric disorders.
- •Patients with any severe and/or uncontrolled diseases, including:
- •Outpatients diagnosed through medical history; inpatients diagnosed based on past medical history and current medical history indicating ≥ Grade 2 myocardial ischemia or myocardial infarction, ≥ Grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
- •Active or uncontrolled severe systemic infections (≥ Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Grade 2).
- •Infectious diseases such as cirrhosis, active hepatitis*, syphilis, human immunodeficiency virus (HIV), etc. *Reference for hepatitis B: hepatitis B surface antigen (HBsAg) positive and Hepatitis B Virus (HBV) DNA test value exceeds the upper limit of normal; Reference for hepatitis C: Hepatitis C Virus (HCV) antibody positive and HCV viral titer test value exceeds the upper limit of normal.
- •History of immunodeficiency, acquired or congenital immunodeficiency diseases, or organ transplantation.
- •Pregnancy or currently breastfeeding or planning to breastfeed during the study.
- •Presence of metal objects in the body (dentures, contraceptive rings, metal implants, metal clips, etc.) and claustrophobia.
- •Allergic reactions to the investigational drug, its metabolites, or excipients.
- •Use of the investigational drug or participation in drug clinical trials within the two months before medication.
- •Difficulty with or intolerance to MRI scans.
- •Subjects who cannot or will not comply with the hospital management regulations.
- •According to the investigator's judgment, patients with accompanying diseases that pose a serious risk to patient safety or may interfere with the completion of the study, or patients deemed unsuitable for inclusion for other reasons.
Arms & Interventions
Polysaccharide superparamagnetic iron oxide injection
Experimental
Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3 mg/kg dose
Intervention: Polysaccharide superparamagnetic iron oxide injection (Drug)
Outcomes
Primary Outcomes
Degree of vascular stenosis
Time Frame: 0 hour after administration
Vascular stenosis degree
The number of vascular segments with lesions
Time Frame: 0 hour after administration
The number of vascular segments with lesions after administration
Lesion length
Time Frame: 0 hour after administration
Vascular lesion length
Secondary Outcomes
- Myocardium T1 values(0 hour after administration)
- Signal-to-noise ratio(0 hour after administration)
- Adverse event rate(Baseline up to 24 hours after administration)
- Serum ferritin(Baseline up to 30 days and 60 days after administration)
- Total iron-binding capacity(Baseline up to 30 days and 60 days after administration)
- Serum iron(Baseline up to 24 hours after administration)
- Image quality scores(0 hour after administration)
- Contrast-to-noise ratio(0 hour after administration)
- Serum transferrin saturation(Baseline up to 30 days and 60 days after administration)
Investigators
Study Sites (1)
Loading locations...
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