DiabetesPhase 1/2NCT06051565
Cardiovascular Contrast-enhanced Magnetic Resonance Imaging Using Polysaccharide Superparamagnetic Iron Oxide Injection in Diabetic Patients
A Phase 1/2 study testing Polysaccharide superparamagnetic iron oxide injection in people with Diabetes and Magnetic Resonance Imaging, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Magnetic Resonance Imaging
- What is being tested?
- Polysaccharide superparamagnetic iron oxide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2021to 15 Sep 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
About this study
Official title: 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.
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.
- Conditions
- Diabetes, Magnetic Resonance Imaging
- Being tested
- Polysaccharide superparamagnetic iron oxide injection
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysaccharide superparamagnetic iron oxide injectionDrug
Polysaccharide superparamagnetic iron oxide injection can be used for the treatment of iron-deficiency anemia and for magnetic resonance imaging enhancement.
| Study group | Role | What they receive |
|---|---|---|
| Polysaccharide superparamagnetic iron oxide injection | Experimental | Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3 mg/kg dose Receives: Drug: Polysaccharide superparamagnetic iron oxide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of vascular segments with lesions
The number of vascular segments with lesions after administration
Measured: 0 hour after administration
Lesion length
Vascular lesion length
Measured: 0 hour after administration
Degree of vascular stenosis
Vascular stenosis degree
Measured: 0 hour after administration
Secondary outcomes (9)
Image quality scores
Vascular image quality was scored on a 4-point scale. 1 = Vessels not assessable due to poor image quality; 2 = Vessels visualized but only gross features (size/patency) confidently assessable; 3 = Vessels well defined and evaluable for structural pathology with high confidence; 4 = Excellent vessel definition with sharp borders such that fine details can be evaluated with high confidence.
Measured: 0 hour after administration
Myocardium T1 values
Changes from baseline in the longitudinal relaxation value of myocardial tissue.
Measured: 0 hour after administration
Signal-to-noise ratio
The strength of a signal relative to the background noise.
Measured: 0 hour after administration
Contrast-to-noise ratio
The visibility and distinguishability of structures or features of interest in an image in the presence of noise.
Measured: 0 hour after administration
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 24 hours after administration
Serum iron
Changes from baseline in the amount of circulating iron that is bound to transferrin and freely circulate in the blood.
Measured: Baseline up to 24 hours after administration
Serum ferritin
Changes from baseline in the concentration of plasma (or serum) ferritin.
Measured: Baseline up to 30 days and 60 days after administration
Total iron-binding capacity
Changes from baseline in the total amount of iron that can be bound by transferrin proteins in the blood.
Measured: Baseline up to 30 days and 60 days after administration
Serum transferrin saturation
Changes from baseline in the value of serum iron divided by the total iron-binding.
Measured: Baseline up to 30 days and 60 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start6 Nov 2021
- Primary completion13 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051565
- Sponsor's protocol ID
- DJTCSCYHT-I-03
- Status last verified
- Oct 2021
- First submitted
- 18 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06051565
- Acronym / sponsor ID
- DJTCSCYHT-I-03
- Conditions
- Diabetes, Magnetic Resonance Imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polysaccharide superparamagnetic iron oxide injection | Experimental | Drug: Polysaccharide superparamagnetic iron oxide injectionIntravenous injected polysaccharide superparamagnetic iron oxide injection at 3 mg/kg dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysaccharide superparamagnetic iron oxide injectionPolysaccharide superparamagnetic iron oxide injection can be used for the treatment of iron-deficiency anemia and for magnetic resonance imaging enhancement. | Drug | Polysaccharide superparamagnetic iron oxide injection |
Primary outcome
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
Degree of vascular stenosis
Time frame: 0 hour after administration
Vascular stenosis degree
9 secondary outcomes
Image quality scores
Time frame: 0 hour after administration
Myocardium T1 values
Time frame: 0 hour after administration
Signal-to-noise ratio
Time frame: 0 hour after administration
Contrast-to-noise ratio
Time frame: 0 hour after administration
Adverse event rate
Time frame: Baseline up to 24 hours after administration
Serum iron
Time frame: Baseline up to 24 hours after administration
Serum ferritin
Time frame: Baseline up to 30 days and 60 days after administration
Total iron-binding capacity
Time frame: Baseline up to 30 days and 60 days after administration
Serum transferrin saturation
Time frame: Baseline up to 30 days and 60 days after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Polysaccharide superparamagnetic iron oxide injection in people with Diabetes and Magnetic Resonance Imaging, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of vascular segments with lesions (time frame: 0 hour after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.