Dynamic Imaging of Variation in Lupus Nephritis



Status:Recruiting
Conditions:Lupus, Nephrology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 65
Updated:12/5/2018
Start Date:March 13, 2018
End Date:December 2020
Contact:Claire Dykas
Email:claire.dykas@ampelbiosolutions.com
Phone:434-977-2675

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To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI),
blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast
enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow,
perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus
nephritis (LN) and compare these parameters to renal biopsy findings to determine whether
DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal
function and pathology in LN.


Inclusion Criteria:

1. Provide written informed consent agreeing to all study procedures, before any study-
specific procedures are done.

2. Male and female subjects 18 to 65 years of age, inclusive.

3. Subjects currently being evaluated for new or recurrent LN with a SOC kidney biopsy
planned OR being evaluated for IgA nephropathy and with a SOC kidney biopsy planned.

4. Patients with LN must meet American College of Rheumatology (ACR) or Systemic Lupus
Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE).

5. Subjects with a life expectancy >6 months.

Exclusion Criteria:

1. Participation in another investigational study during same time period.

2. Contraindication to receiving a GBCA.

3. More than 2 previous lifetime exposures to a GBCA.

4. Any contraindication to MRI, including metal implants, claustrophobia or morbid
obesity.

5. Acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] <40 mL
per minute per 1.73 m2).

6. Subject requiring dialysis.

7. Presence of pre-existing renal disease unrelated to SLE or IgA nephropathy,
respectively.

8. Acute renal insufficiency of any severity caused by the hepato-renal syndrome.

9. Previous or pre-existing nephrogenic systemic fibrosis.

10. History of clinically significant anti-phospholipid syndrome.

11. Chronic liver function impairment, indicated by liver function tests (aspartate
aminotransferase [AST], alanine aminotransferase [ALT]) >2-fold upper limit of normal.

12. Platelet count <50,000/μL.

13. Hemoglobin <8.0 g/dL.

14. History of or presence of central nervous system (CNS) disease such as active lupus
cerebritis or multiple sclerosis that might compromise blood brain barrier function.

15. Infection that is clinically relevant, particularly hepatitis B virus (HBV), hepatitis
C virus (HCV) and/or human immunodeficiency virus (HIV).

16. Pregnant or nursing females, or females not using effective contraception.

17. Inability or unwillingness to return to the research site clinic for study visits at
baseline and at 6 months.
We found this trial at
7
sites
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-9110
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-445-2631
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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13001 East 17th Place
Aurora, Colorado 80045
Phone: 303-724-7611
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Aurora, CO
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-1964
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-4997
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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550 1st Ave
New York, New York 10016
(212) 263-7300
Phone: 646-501-7400
New York University School of Medicine NYU School of Medicine has a proud history that...
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New York, NY
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New York, New York 10034
Phone: 212-305-0856
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New York, NY
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