Phase 4
Completed N=21
Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
Source: ClinicalTrials.gov NCT02628106 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI — 22.04 1/ms
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI |
22.04 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02628106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.