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

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02628106
• Other study ID #: BOLD-1981
• Status: Recruiting
• Phase: Phase 4
• First received: December 1, 2015
• Last updated: December 9, 2015
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: West China Hospital
• Contact: zhi ch li, bachelor
• Phone: +8613795581617
• Email: wangcaizi2[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Lipo-PGE1
all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days

Locations

Country	Name	City	State
China	Zhichengli	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of tissue content of deoxyhemoglobin assessed by BOLD-MRI	R2* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue .	at baseline and after 14 days of lipo-PGE1 administration	Yes