Phase 4 N=21 Treatment

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

Diabetic Nephropathy

Bottom Line

View on ClinicalTrials.gov: NCT02628106 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI — 22.04 1/ms

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lipo-PGE1 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West China Hospital
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI	22.04	—

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.

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.

View full record on ClinicalTrials.gov →

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.