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

NCT05045872 | Completed Phase 1 DMC

• 1 other identifier: 013
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (12)

• the degree of renal artery stenosis

  Degree of renal artery stenosis assessed by Magnetic Resonance Imaging and renal angiography

  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.

  baseline and after intervention

• change of hemoglobin level

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

  baseline,72 hours,30 days,3 months

• serum creatinine

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

  baseline,72 hours,30 days,3 months

• Urine routine

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

  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.

  baseline,72 hours,30 days,3 months

• Retinol binding protein

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

  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.

  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.

  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.

  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.

  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.

  baseline,72 hours,30 days,3 months

Study Arms (1)

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.

Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle

Interventions

domestic polysaccharide superparamagnetic iron oxide nanoparticle DRUG

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.

Also known as: ferumoxytol

ferumoxytol-enhanced renal magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Artery Obstruction

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Chunjian Li, Dr,PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., MD, Ph.D, Director of CCU Ward

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: September 16, 2021
• Study Start: September 17, 2021
• Primary Completion: May 25, 2024
• Study Completion: September 3, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)