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

NCT02628106 | Completed Phase 4 Results DMC

• 1 other identifier: BOLD-1981
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and after 14days of lipo-PGE1 intravenously

Study Arms (1)

Lipo-prostaglandin E1

EXPERIMENTAL

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

Drug: Lipo-PGE1

Interventions

Lipo-PGE1 DRUG

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

Also known as: alprostadil

Lipo-prostaglandin E1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of chronic kidney disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Zhichengli

Chengdu, Sichuan, 641000, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

the small study population and absence of a placebo group and healthy volunteers.

Results Point of Contact

• Title: Mr.Zhi-cheng Li
• Organization: West China Hospital of Sichuan University

wangcaizi2@163.com

+86 13795581617

Study Officials

• fang liu, doctor

  Department of Nephrology, West China Hospital of Sichuan University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A graduate student

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 29, 2016
• Results First Posted: May 24, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)