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

NCT ID: NCT02628106

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Diabetic Nephropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipo-prostaglandin E1

all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.

Group Type: EXPERIMENTAL

Lipo-PGE1

Intervention Type: DRUG

all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days

Interventions

Lipo-PGE1

all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days

Intervention Type: DRUG

Other Intervention Names

alprostadil

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhicheng Li

A graduate student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

fang liu, doctor

Role: STUDY_CHAIR

Department of Nephrology, West China Hospital of Sichuan University

Locations

Zhichengli

Chengdu, Sichuan, China

Countries

China

Other Identifiers

BOLD-1981

Identifier Type: -

Identifier Source: org_study_id