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

NCT ID: NCT05687864

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-17
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Magnetic Resonance Imaging; Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Polysaccharide superparamagnetic ferric oxide injection

Participants will receive one single dose of 1mg/kg or 2mg/kg or 3mg/kg or 4mg/kg or 5mg/kg of Polysaccharide superparamagnetic ferric oxide injection on Day 1.

Group Type: EXPERIMENTAL

Polysaccharide superparamagnetic ferric oxide injection

Intervention Type: DIAGNOSTIC_TEST

The polysaccharide superparamagnetic ferric oxide injection is a clinical diagnostic reagent

Interventions

Polysaccharide superparamagnetic ferric oxide injection

The polysaccharide superparamagnetic ferric oxide injection is a clinical diagnostic reagent

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qi Yang, Doctor

Role: primary

+86 028-85423837

Other Identifiers

DJTCSCYHT-I-04

Identifier Type: -

Identifier Source: org_study_id