Chronic Kidney DiseasesPhase 1NCT05045872

Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging

A Phase 1 study testing domestic polysaccharide superparamagnetic iron oxide nanoparticle in people with Chronic Kidney Diseases, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Kidney Diseases
What is being tested?: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteChina
Study dates: 17 Sep 2021to 3 Sep 2024
Phase: Phase 1
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≧ 18 years, < 75 years;
Patients who planned renal angiography (hypertension 、renal failure、atherosclerosis）;
Patients with normal renal function or CKD stage 1-5(Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition);
Patients themselves or authorized families to sign informed consent voluntarily.

Who cannot join

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 Claustrophobia ) 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 women;
Hearing impaired persons;
Cardiac function grade III-IV;

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029

Other trials in China

About this study

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

Conventional contrast-enhanced magnetic resonance imaging is typically performed with extracellular gadolinium chelates, which is often limited in patients with CKD owing to the risk of nephrogenic systemic fibrosis. Ferumoxytol, a novel contrast medium, can be used as an "off-label" contrast agent for magnetic resonance imaging. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in patients with estimated glomerular filtration rates <30mL/min and there are reports in the literature for its safe use and utility in both adult and pediatric patients with CKD. The study is designed to evaluate the diagnostic performance of ferumoxytol-enhanced magnetic resonance imaging in patients suspected of renal artery stenosis, investigate the correlation between renal cortical T2*(T2*=1/R2*) and renal function, and develop an automatic algorithms for renal vessel segmentation.

Read the detailed description

This study is a single-center, prospective, controlled and diagnostic clinical trial to evaluate renal vasculature and renal function with ferumoxytol-enhanced magnetic resonance imaging using domestic polysaccharide superparamagnetic iron oxide injection as the contrast agent. This study will enroll 40 patients with or without renal impairment that are expected to undergo renal artery angiography in China. The investigators will record the baseline data of patients after admission. Patients will receive enhanced renal magnetic resonance imaging with polysaccharide superparamagnetic iron oxide nanoparticle to assess renal vasculature and renal function. The related laboratory indices will be reviewed at 24-72 h after magnetic resonance imaging, and then patients will receive renal angiography. The indices will be reexamined at 1 month and 3 months after magnetic resonance imaging. 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 results of MR imaging including image quality, degree of vascular stenosis, and quantitative T2* values of the renal cortex will be evaluated independently by two experienced radiologists. The degree of stenosis of the same vessels assessed by Quantitative Coronary Analysis (QCA) will be used for comparison with MR results. All clinical adverse events will be recorded by investigators.

Conditions: Chronic Kidney Diseases
Being tested: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Renal Artery Stenosis
Medical subject headings: Renal Insufficiency, Chronic, Renal Artery Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

domestic polysaccharide superparamagnetic iron oxide nanoparticleDrug
Also called ferumoxytol
Patients will receive contrast-enhanced renal magnetic resonance imaging with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography. Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

Study groups in NCT05045872
Study group	Role	What they receive
ferumoxytol-enhanced renal magnetic resonance imaging	Experimental	Patients will receive ferumoxytol-enhanced renal magnetic resonance imaging before renal angiography. Ferumoxytol (510 mg/17mL; Chia Tai Tianqing Pharmaceutical Group Co Ltd, Nanjing, China) will be diluted at 1:4 (v/v) and intravenously infused into the antecubital vein at a dose of 3 mg/kg with an infusion speed of 0.07 mL/s. Receives: Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle

What is being measured

The primary outcome is the main question the study is designed to answer.

the degree of renal artery stenosis
Degree of renal artery stenosis assessed by Magnetic Resonance Imaging and renal angiography
Measured: baseline and after intervention
quantitative cortical T2* value
the quantitative T2* value of the renal cortex will be measured bilaterally at the upper and lower poles by drawing six equal-sized, non-overlapping operator-dependent regions of interest (ROI) to calculate average quantitative T2* values.
Measured: baseline and after intervention
change of hemoglobin level
hemoglobin examination of patients before and after examination to evaluate anemia.
Measured: baseline,72 hours,30 days,3 months
serum creatinine
serum creatinine examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 days,3 months
Urine routine
Urine routine examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 days,3 months
24-hour urine biochemistry
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 days,3 months
Retinol binding protein
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 days,3 months
Neutrophil gelatinase-associated lipocalin
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Measured: baseline,72 hours,30 days,3 months
Serum iron
Determination of serum iron before and after MRA to evaluate the changes of iron content in peripheral blood.
Measured: baseline,72 hours,30 days,3 months
Ferritin
Determination of serum ferritin before and after MRA to evaluate the changes of iron content in peripheral blood.
Measured: baseline,72 hours,30 days,3 months
Transferrin
Determination of serum transferrin before and after MRA to evaluate the changes of iron content in peripheral blood.
Measured: baseline,72 hours,30 days,3 months
serum cystatin C
Determination of serum cystatin C before and after examination to evaluate the changes of renal function.
Measured: baseline,72 hours,30 days,3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 20213 Sep 2024

First posted16 Sep 2021
Study start17 Sep 2021
Primary completion25 May 2024
Study completion3 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05045872
Sponsor's protocol ID: 013
Status last verified: Sep 2024
First submitted: 21 Aug 2021
Last updated: 25 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Chronic Kidney Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Renal Contrast-enhanced Magnetic Resonance Imaging
ClinicalTrials.gov ID: NCT05045872
Acronym / sponsor ID: 013
Conditions: Chronic Kidney Diseases
Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Renal Artery Stenosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study start: 17 Sep 2021 (actual)
Primary completion: 25 May 2024 (actual)
Study completion: 3 Sep 2024 (actual)
First posted: 16 Sep 2021 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ferumoxytol-enhanced renal magnetic resonance imaging	Experimental	Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticlePatients will receive ferumoxytol-enhanced renal magnetic resonance imaging before renal angiography. Ferumoxytol (510 mg/17mL; Chia Tai Tianqing Pharmaceutical Group Co Ltd, Nanjing, China) will be diluted at 1:4 (v/v) and intravenously infused into the antecubital vein at a dose of 3 mg/kg with an infusion speed of 0.07 mL/s.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≧ 18 years, < 75 years;
Patients who planned renal angiography (hypertension 、renal failure、atherosclerosis）;
Patients with normal renal function or CKD stage 1-5(Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition);
Patients themselves or authorized families to sign informed consent voluntarily.

Key exclusion criteria (10 listed)

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 Claustrophobia ) 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 women;
Hearing impaired persons;

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
domestic polysaccharide superparamagnetic iron oxide nanoparticleAlso: ferumoxytolPatients will receive contrast-enhanced renal magnetic resonance imaging with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography. Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.	Drug	ferumoxytol-enhanced renal magnetic resonance imaging

Primary outcome

the degree of renal artery stenosis
Time frame: baseline and after intervention
Degree of renal artery stenosis assessed by Magnetic Resonance Imaging and renal angiography
quantitative cortical T2* value
Time frame: baseline and after intervention
the quantitative T2* value of the renal cortex will be measured bilaterally at the upper and lower poles by drawing six equal-sized, non-overlapping operator-dependent regions of interest (ROI) to calculate average quantitative T2* values.
change of hemoglobin level
Time frame: baseline,72 hours,30 days,3 months
hemoglobin examination of patients before and after examination to evaluate anemia.
serum creatinine
Time frame: baseline,72 hours,30 days,3 months
serum creatinine examination of patients before and after examination to evaluate kidney function.
Urine routine
Time frame: baseline,72 hours,30 days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
24-hour urine biochemistry
Time frame: baseline,72 hours,30 days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Retinol binding protein
Time frame: baseline,72 hours,30 days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Neutrophil gelatinase-associated lipocalin
Time frame: baseline,72 hours,30 days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Serum iron
Time frame: baseline,72 hours,30 days,3 months
Determination of serum iron before and after MRA to evaluate the changes of iron content in peripheral blood.
Ferritin
Time frame: baseline,72 hours,30 days,3 months
Determination of serum ferritin before and after MRA to evaluate the changes of iron content in peripheral blood.
Transferrin
Time frame: baseline,72 hours,30 days,3 months
Determination of serum transferrin before and after MRA to evaluate the changes of iron content in peripheral blood.
serum cystatin C
Time frame: baseline,72 hours,30 days,3 months
Determination of serum cystatin C before and after examination to evaluate the changes of renal function.

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 25 Sep 2024.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Diseases

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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.

Chunjian Li, Dr,PhD principal investigator

Study Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 10 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 25 Sep 2024. 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 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.

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 degree of renal artery stenosis (time frame: baseline and after intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05045872.

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 25 Sep 2024.