Dynamic Imaging of Variation in Lupus Nephritis

Lupus Nephritis Clinical Trial

— DIVINE  

Official title:

Dynamic Imaging of Variation in Lupus Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180021
• Other study ID #: RIL-001
• Status: Completed
• Start date: March 13, 2018
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2021
• Source: RILITE Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Procedure:
• MRI
This is a multicenter, non-interventional, pilot study. Eligible subjects will have a baseline MRI of the kidney, including anatomical, DWI, BOLD, T1rho, and DCE-MRI, utilizing a macrocyclic gadolinium-based contrast agent (GBCA), followed by planned standard of care (SOC) renal biopsy and clinical laboratory assessments. Additional serum and urine will be collected from subjects at baseline for analysis of research biomarkers. Following the results of the biopsy and clinical laboratory assessments, subjects will be treated for their underlying disease at the discretion of the investigator. At 6 months, subjects will return to the clinic for a second MRI, SOC clinical and laboratory evaluation and collection of serum and urine for analysis of research biomarkers.

Locations

Country	Name	City	State
United States	The Regents of the University of Colorado	Aurora	Colorado
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	New York University School of Medicine	New York	New York
United States	The Trustees of Columbia University in the City of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
RILITE Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion Weight Imaging	Diffusion weighted imaging (DWI) measures ADC values that quantify the combined effects of blood microcirculation and Brownian motion of water molecules within the interstitial space.	7 Months
Primary	Blood Oxygen Level Dependent Imaging	Blood oxygen level dependent (BOLD) imaging has been widely used to analyze blood flow in various 15 and is the preferred method to detect regional differences in blood flow.	7 Months
Primary	T1rho Imaging	T1rho (T1rho) imaging is an MRI technique that is sensitive to the presence of macromolecules, such as collagen and proteoglycan 13.	7 Months
Primary	Dynamic Contrast Enhanced Magnetic Resonance Imaging	Dynamic contrast enhanced (DCE) MRI (DCE-MRI) is an imaging method where T1-weighted MRI scans are acquired dynamically after injection of an MRI contrast agent (e.g., macrocylic gadolinium).	7 Months