Ignite Creation Date:
2024-05-06 @ 1:07 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01731054
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2012-11-08
Brief Title:
Functional MRI in Lupus Nephritis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Noninvasive Assessment Of Renal Activity And Damage Using Renal Functional MRI In Normal Healthy Volunteers And Subjects With Lupus Nephritis
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of the study are as follows To develop and optimize a renal functional magnetic resonance imaging MRI protocol consisting of Diffusion-Weighted Magnetic Resonance Imaging DW-MRI Blood-Oxygen- Level-Dependent MRI BOLD-MRI Arterial Spin Labeling MRI ASL-MRI Phase Contrast MRI PC-MRI and T1rho-MRI To compare renal functional MRI cross-sectional readouts between normal healthy volunteers NHV and lupus nephritis LN participants
The secondary objectives of this study are as follows Explore whether renal functional MRI techniques discriminate between renal inflammatory activity and damage in lupus nephritis LN To examine whether renal functional MRI measurements correlate with laboratory features of renal involvement and renal function in participants with lupus nephritis LN
The secondary objectives of this study are as follows Explore whether renal functional MRI techniques discriminate between renal inflammatory activity and damage in lupus nephritis LN To examine whether renal functional MRI measurements correlate with laboratory features of renal involvement and renal function in participants with lupus nephritis LN
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None