Clinical trial NCT02628106: Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
Official title: Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and after lipo-PGE1 administration to acquire bilateral renal cortical R2\*(CR2\*) and medullary R2\* (MR2\*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.

Detailed description: R2\* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks, Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. The R2\* map was windowed from 0 to 60 s-1.

Regions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. Three ROIs were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral cortex and medulla. To prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. Thereafter, assuming the tests were coincident, the results were the averaged.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic kidney disease

Exclusion Criteria:

* Intolerance to lipo-PGE1, contraindication for MRI, concurrent urinary tract infection, acute kidney injury, acute cardiovascular and cerebrovascular complications and diabetic emergencies, with the use of corticosteroid and diureses.

Primary outcomes:
measure: the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI
timeFrame: baseline and after 14days of lipo-PGE1 intravenously
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Zhichengli
state: Sichuan
Study officials:
affiliation: Department of Nephrology, West China Hospital of Sichuan University
name: fang liu, doctor
role: STUDY_CHAIR
References: