Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lipo-PGE1
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy
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.
Sites / Locations
- Zhichengli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lipo-prostaglandin E1
Arm Description
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
Outcomes
Primary Outcome Measures
the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02628106
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipo-prostaglandin E1
Arm Type
Experimental
Arm Description
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
Intervention Type
Drug
Intervention Name(s)
Lipo-PGE1
Other Intervention Name(s)
alprostadil
Intervention Description
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Primary Outcome Measure Information:
Title
the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI
Description
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
Time Frame
baseline and after 14days of lipo-PGE1 intravenously
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fang liu, doctor
Organizational Affiliation
Department of Nephrology, West China Hospital of Sichuan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhichengli
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
641000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
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