CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Lipo-PGE1drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02628106
NCT02628106Phase 4Completed

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

West China Hospital·interventional·Posted Dec 11, 2015·Updated Dec 29, 2016

In Brief

A Phase 4 clinical trial evaluating Lipo-PGE1 for Diabetic Nephropathy. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 11, 2015
Enrollment StartDec 1, 2015
Primary CompletionJan 1, 2016
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.6 years ago

Interventions

Lipo-PGE1drug

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