Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0062
Source ID: NCT05045872
Associated Drug: Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
Title: Assessment of Renal Vasculature and Function with Ferumoxytol-enhanced Magnetic Resonance Imaging
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Outcome Measures: Primary: 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 |
Sponsor/Collaborators: Sponsor: The First Affiliated Hospital with Nanjing Medical University | Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-09-17
Completion Date: 2024-09-03
Results First Posted:
Last Update Posted: 2024-09-25
Locations: First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China
URL: https://clinicaltrials.gov/show/NCT05045872