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the Accuracy and Safety of Renal Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

Primary Purpose

Chronic Kidney Diseases

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

domestic polysaccharide superparamagnetic iron oxide nanoparticle

About this trial

This is an interventional diagnostic trial for Chronic Kidney Diseases focused on measuring Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Renal Artery Stenosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≧ 18 years, < 65 years;
Patients who planned coronary angiography (hypertension 、renal failure、atherosclerosis）;
Patients with normal renal function or CKD stage 1-3;
Patients themselves or authorized families to sign informed consent voluntarily.

Exclusion Criteria:

Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
Patients who can ' t accept magnetic resonance examination because of psychological ( such as autism syndrome ) or physical reasons ( such as metal retention in the body );
Malignancies or other comorbid conditions with life expectancy less than 1 year;
Pregnant or lactating woman;
Hearing impaired persons;
Cardiac function grade III-IV;
History of coronary stenting or coronary artery bypass grafting;
Patients who were taking other iron agents orally or intravenously;
Patients with hemosiderin deposition or hemochromatosis;
Patients with acute coronary syndromes;
Any other patients that researcher deems it's unsuitable to be admitted.

Sites / Locations

First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EMRA

Arm Description

Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography.

Outcomes

Primary Outcome Measures

the degree of renal artery stenosis

Degree of renal artery stenosis assessed by Magnetic Resonance Imaging

the degree of renal artery stenosis

Degree of renal artery stenosis assessed by renal artery angiography

change of hemoglobin level

hemoglobin examination of patients before and after examination to evaluate anemia.

serum creatinine

serum creatinine examination of patients before and after examination to evaluate kidney function.

Urine routine

Urine routine examination of patients before and after examination to evaluate kidney function.

24-hour urine biochemistry

24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.

Retinol binding protein

Retinol binding protein examination of patients before and after examination to evaluate kidney function.

Neutrophil gelatinase-associated lipocalin

Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.

Serum iron

Determination of serum iron before and after MRA to evaluate the changes of iron content in peripheral blood.

Ferritin

Determination of serum ferritin before and after MRA to evaluate the changes of iron content in peripheral blood.

Transferrin

Determination of serum transferrin before and after MRA to evaluate the changes of iron content in peripheral blood.

Change of iron content in tissues between different time points

Evaluation of tissue iron content by T1W MRI before and after MRA.

Secondary Outcome Measures

Full Information

NCT ID

NCT05045872

First Posted

August 21, 2021

Last Updated

May 8, 2023

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05045872

Brief Title

the Accuracy and Safety of Renal Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

Official Title

Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Renal Artery Contrast-enhanced Magnetic Resonance Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a single-center, prospective, controlled and diagnostic clinical trial to explore the effectiveness and safety of domestic polysaccharide superparamagnetic iron oxide injection for contrast-enhanced renal artery magnetic resonance. This study will enroll 40 patients scheduled for renal arteriography in China.The investigators will record the baseline data of patients after admission.Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle to assess renal artery stenosis.The related laboratory indexes will be reviewed at 72 h after Magnetic Resonance Imaging ,and then patients will receive renal angiography . The indexes were reexamined at 1 month and 3 months after magnetic resonance imaging. The investigators will Record all clinical adverse events. In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination.The investigators will Record all clinical adverse events in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Diseases

Keywords

Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Renal Artery Stenosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EMRA

Arm Type

Experimental

Arm Description

Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography.

Intervention Type

Drug

Intervention Name(s)

domestic polysaccharide superparamagnetic iron oxide nanoparticle

Intervention Description

Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

Primary Outcome Measure Information:

Title

the degree of renal artery stenosis

Description

Degree of renal artery stenosis assessed by Magnetic Resonance Imaging

Time Frame

baseline

Title

the degree of renal artery stenosis

Description

Degree of renal artery stenosis assessed by renal artery angiography

Time Frame

baseline

Title

change of hemoglobin level

Description

hemoglobin examination of patients before and after examination to evaluate anemia.

Time Frame