Trial Outcomes & Findings for Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy (NCT NCT02628106)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

baseline and after 14days of lipo-PGE1 intravenously

Results posted on

2016-12-29

Participant Flow

Our overall recruiting cycle for 40 days, mainly for patients with chronic kidney disease patients, which is divided into diabetic nephropathy and non-diabetic patients

Chronic kidney disease patients were divided into diabetic nephropathy and non-diabetic group, ordinary chronic kidney disease patients with diabetes mellitus were excluded

Participant milestones

Participant milestones
Measure	Diabetic Nephropathy,Chronic Kidney Disease all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lipo-prostaglandin E1 n=21 Participants all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Age, Continuous	59 years STANDARD_DEVIATION 13 • n=5 Participants
Gender Female	12 Participants n=5 Participants
Gender Male	9 Participants n=5 Participants
Region of Enrollment China	21 participants n=5 Participants
R2* values	23.32 1/ms STANDARD_DEVIATION 6.48 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and after 14days of lipo-PGE1 intravenously

Population: A random sample, west China hospital, in accord with a standard 21 people,age \> 18 years

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

Outcome measures

Outcome measures
Measure	Diabetic Nephropathy,Chronic Kidney Disease n=21 Participants all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI	22.04 1/ms Standard Deviation 6.15

Adverse Events

Diabetic Nephropathy,Chronic Kidney Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr.Zhi-cheng Li

West China Hospital of Sichuan University

Phone: +86 13795581617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place