Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging

Chronic Kidney Diseases Clinical Trial

Official title:

Single-center, Multiple-strength, Single-dose Phase I Clinical Trial to Evaluate the Effect of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687864
• Other study ID #: DJTCSCYHT-I-04
• Status: Recruiting
• Phase: Phase 1
• Start date: June 17, 2023
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polysaccharide super paramagnetic ferric oxide injection is an iron supplement developed for patients with iron deficiency anemia. Due to its characteristics, it has the potential to be a contrast agent. The DJTCSCYHT-I-04 study is a single-center, multiple-strength and single-dose phase I clinical study on cardiovascular MRI in patients with chronic kidney disease, aiming to investigate the effects and safety of multi-strength, single-dose at different time points, and to provide reference for clinical diagnosis and MRI enhancement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.;
• Age: =18 years old (at the time of signing the informed consent), gender is not limited;
• Patients diagnosed with Chronic Kidney Disease (CKD, 2012 KDIGO Guidelines);
• Eastern Cooperative Oncology Group (ECOG) score 0~1; Expected survival =3 months;
• Serum ferritin = 1000µg/L and transferrin saturation = 50%;
• The major organs function are good and meet the following criteria:

1. blood routine examination:

1. Hemoglobin = 90g/L

2. Neutrophil count (NEUT) =1.5×109/L;

3. Platelet count (PLT) = 75×109/L;

2. Biochemical examination should meet the following standards:

1. Total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN);

2. Alanine transferase (ALT), aspartate transferase (AST) and gamma glutamyltransferase (gamma-GGT) = 3ULN;

3. Left ventricular ejection fraction (LVEF) =50%.

• Women of reproductive age should agree to use effective birth control during the study period and for 6 months after the study, and have a negative serum-pregnancy test within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.

Exclusion Criteria:

• Had or currently have malignant tumors within 3 years. The following three conditions

were eligible for inclusion:

1. patients with other malignancies treated with a single operation achieved continuous 5-year disease-free survival (DFS);

2. Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)];

3. The disease was stable as assessed by the investigators, and the concomitant drugs did not affect medication during the trial and follow-up period.

• Subjects with any severe and/or uncontrolled medical conditions, including:

1. Poorly controlled hypertension (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg) or poorly controlled hypotension (systolic blood pressure <90mmHg or diastolic blood pressure <60 mmHg);

2. Have = grade 2 myocardial ischemia or myocardial infarction and/or severe or malignant arrhythmias [including QTc =450ms in men, QTc =470ms in women] and/or = grade 2 congestive heart failure [New York Heart Association (NYHA)];

3. Active infection (=NCI, CTC AE 5.0, Grade 2);

4. Viral hepatitis, syphilis, HIV and other infectious diseases;

5. A history of immunodeficiency, including acquired or congenital immunodeficiency diseases, or a history of organ transplantation;

6. People who have epilepsy and require treatment.

• Research and treatment related:

1. Patients with iron deficiency anemia;

2. Subjects who are allergic to intravenous iron preparations, the investigational drug or any of its components, or two or more types of drugs;

3. Subjects who plan to undergo magnetic resonance imaging during the study period and during follow-up.

• Participants who have participated in other clinical trials of drugs or medical device within 28 days before the start of the study treatment;
• Those who have a history of psychotropic drug abuse and cannot abstain or have mental disorders;
• Pregnant or lactating women;
• Patients with non-magnetic compatible metal foreign bodies (false teeth, contraceptive rings, metal implants, metal clips, etc.) and claustrophobia; Patients with difficulty or inability to tolerate MRI scanning;
• Subjects with concomitant diseases that, in the investigator's judgment, seriously endanger subjects' safety or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Magnetic Resonance Imaging
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Polysaccharide superparamagnetic ferric oxide injection
The polysaccharide superparamagnetic ferric oxide injection is a clinical diagnostic reagent

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal-to-Noise Ratio (SNR)	On the basis of vascular segments, the signal-to-noise ratio at different doses and time points was calculated by magnetic resonance imaging.	Before administration, 5minutes, 24 hours, 48 hours after administration
Primary	Contrast to noise ratio (CNR)	On the basis of vascular segments, the Contrast to noise ratio at different doses and time points was calculated by magnetic resonance imaging.	Before administration, 5minutes, 24 hours, 48 hours after administration
Primary	Image quality score before administration	On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate.	Before administration
Primary	Image quality score at 5 minutes	On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate.	5 minutes after administration
Primary	Image quality score at 24 hours	On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate.	24 hours after administration
Primary	Image quality score at 48 hours	On the basis of vascular segments, the image quality of different doses at different time points was evaluated by magnetic resonance imaging. 4 points: the blood vessel edge is clear and sharp, without image artifacts, which can support the judgment of high confidence; 3 points: The overall portrayal effect of blood vessels was satisfactory, the anatomical structure of blood vessels was clear enough to meet the requirements of disease diagnosis, and there were mild image artifacts; 2 points: Blood vessels were visible, but only the local structure size or blood vessel patency could be judged, with moderate image artifacts; 1 point: poor image quality, serious image artifacts, unable to distinguish blood vessels and other tissues, unable to evaluate.	48 hours after administration
Secondary	T2* value of Liver	T2* signals in the liver were quantitatively detected by magnetic resonance scanning	Before administration, and day 28, day 60, day 90 after administration
Secondary	R2 value of Liver	R2 signals in the liver were quantitatively detected by magnetic resonance scanning	Before administration, and day 28, day 60, day 90 after administration
Secondary	Magnetic sensitivity of brain tissue	Magnetic resonance scanning was used to quantitatively detect magnetic sensitivity of brain tissue	Before administration, and day 28, day 60, day 90 after administration
Secondary	Incidence of adverse events	The incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)	From the enrollment of the subjects to 90 days after administration
Secondary	Incidence of severe adverse events	The incidence of severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0)	From the enrollment of the subjects to 90 days after administration