Clinical trial NCT03180021: Dynamic Imaging of Variation in Lupus Nephritis
Official title: Dynamic Imaging of Variation in Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Nephritis
Lead sponsor: RILITE Foundation
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Lupus Nephritis or IgA neuropathy selected at academic sites listed.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diffusion Weight Imaging
timeFrame: 7 Months
measure: Blood Oxygen Level Dependent Imaging
timeFrame: 7 Months
measure: T1rho Imaging
timeFrame: 7 Months
measure: Dynamic Contrast Enhanced Magnetic Resonance Imaging
timeFrame: 7 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Regents of the University of Colorado
state: Colorado
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: The Trustees of Columbia University in the City of New York
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: