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

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ClinicalTrials.gov Identifier: NCT02628106
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : May 24, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Zhicheng Li, West China Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Lipo-PGE1 Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients
Study Start Date : December 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lipo-prostaglandin E1
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
 Drug: Lipo-PGE1
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Other Name: alprostadil


Outcome Measures
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Primary Outcome Measures :
  1. the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628106


Locations
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China, Sichuan
Zhichengli
Chengdu, Sichuan, China, 641000
Sponsors and Collaborators
West China Hospital
Investigators
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Study Chair: fang liu, doctor Department of Nephrology, West China Hospital of Sichuan University
More Information
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Responsible Party: Zhicheng Li, A graduate student, West China Hospital
ClinicalTrials.gov Identifier: NCT02628106    
Other Study ID Numbers: BOLD-1981
First Posted: December 11, 2015    Key Record Dates
Results First Posted: May 24, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Hypoxia
Urologic Diseases
Signs and Symptoms, Respiratory
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents