Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy

Phase 4

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: Lipo-PGE1

• Registration Number: NCT02628106
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Results First Submitted: 2016-03-10
• Results First Submitted QC: 2016-04-14
• Results First Posted: 2016-05-24
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipo-prostaglandin E1	Lipo-PGE1	all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.

Primary Outcome Measures

Name	Time	Method
the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI	baseline and after 14days of lipo-PGE1 intravenously	the R2\* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2\* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue

Trial Locations

Locations (1)

Zhichengli; 🇨🇳 Chengdu, Sichuan, China