Dynamic Imaging of Variation in Lupus Nephritis (DIVINE)

RILITE Foundation

Status: Completed

Conditions: Lupus Nephritis

Treatments: Procedure: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT03180021

RIL-001

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 2 patient groups

Patients with Lupus Nephritis

Treatment:

Procedure: MRI

Patients with IgA Neuropathy

Treatment:

Procedure: MRI