A Phase 4 interventional study of Lipo-PGE1 in Diabetic Nephropathy, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by West China Hospital · Phase 4, Interventional, and Treatment
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.
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.
544 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.
This study's enrollment of 21 is below the median of 80 across 385 interventional studies indexed under Diabetic Nephropathies.
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Exclusion Criteria:
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
Also known as: alprostadil
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
Time frame: baseline and after 14days of lipo-PGE1 intravenously
Our overall recruiting cycle for 40 days, mainly for patients with chronic kidney disease patients, which is divided into diabetic nephropathy and non-diabetic patients
| Milestone | Diabetic Nephropathy,Chronic Kidney Disease |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
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
| 1/ms | Diabetic Nephropathy,Chronic Kidney Disease |
|---|---|
| the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI | 22.04 ± 6.15 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diabetic Nephropathy,Chronic Kidney Disease | — | 0/21 (0%) | 0/21 (0%) |
age \> 18 years
| Age, Continuous(years) | Lipo-prostaglandin E1 |
|---|---|
| Mean | 59 ± 13 |
| Gender(Participants) | Lipo-prostaglandin E1 |
|---|---|
| Female | 12 |
| Male | 9 |
| Region of Enrollment(participants) | Lipo-prostaglandin E1 |
|---|---|
| China | 21 |
| R2* values(1/ms) | Lipo-prostaglandin E1 |
|---|---|
| Mean | 23.32 ± 6.48 |
Plan to share: No
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alprostadil