Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The test-retest reliability and sensitivity of renal functional magnetic resonance imaging (MRI) measurements to detect renal inflammatory activity or damage in normal healthy volunteers (NHV) and participants with lupus nephritis (LN). | Day 1 | |
| The mean difference between normal healthy volunteers (NHV) and lupus nephiritis (LN) groups in renal structural and functional magnetic resonance imaging (MRI) measurements. | Within7 days of renal biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between histological renal activity and chronicity scores and renal functional magnetic resonance imaging (MRI) measurements in participants with lupus nephritis (LN). | Day 1 | |
| Correlation between renal cortical volume and renal functional magnetic resonance imaging (MRI) measurements. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Primary care clinic, community sample. 30 Normal Healthy Volunteers 30 Participants with documented diagnosis of Lupus Nephritis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angelos | California | 90095 | United States | ||
| Research Site |
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood Samples, Urine samples and Renal biopsy tissue samples.
| Day 1 |
| Correlation between renal functional magnetic resonance imaging (MRI) measurements and renal function as assessed by estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula. | Day 1 |
| Correlation between renal functional magnetic resonance imaging (MRI) measurements and proteinuria. | Day 1 |
| Torrance |
| California |
| 90502 |
| United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | Columbus | Ohio | 3210 | United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |