Dynamic Imaging of Variation in Lupus Nephritis

NCT03180021 | Completed

• 1 other identifier: RIL-001
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 6

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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Patients with Lupus Nephritis

Procedure: MRI

Patients with IgA Neuropathy

Procedure: MRI

Interventions

MRI PROCEDURE

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.

Patients with IgA Neuropathy; Patients with Lupus Nephritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Lupus Nephritis or IgA neuropathy selected at academic sites listed.

You may qualify if:

• Provide written informed consent agreeing to all study procedures, before any study- specific procedures are done.
• Male and female subjects 18 to 65 years of age, inclusive.
• 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.
• Patients with LN must meet American College of Rheumatology (ACR) or Systemic Lupus Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE).
• Subjects with a life expectancy \>6 months.

You may not qualify if:

• Participation in another investigational study during same time period.
• Contraindication to receiving a GBCA.
• More than 2 previous lifetime exposures to a GBCA.
• Any contraindication to MRI, including metal implants, claustrophobia or morbid obesity.
• Acute or chronic severe renal insufficiency (glomerular filtration rate \[GFR\] \<40 mL per minute per 1.73 m2).
• Subject requiring dialysis.
• Presence of pre-existing renal disease unrelated to SLE or IgA nephropathy, respectively.
• Acute renal insufficiency of any severity caused by the hepato-renal syndrome.
• Previous or pre-existing nephrogenic systemic fibrosis.
• History of clinically significant anti-phospholipid syndrome.
• Chronic liver function impairment, indicated by liver function tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]) \>2-fold upper limit of normal.
• Platelet count \<50,000/μL.
• Hemoglobin \<8.0 g/dL.
• 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.
• Infection that is clinically relevant, particularly hepatitis B virus (HBV), hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV).

Sponsors & Collaborators

• RILITE Foundation: lead

Study Sites (6)

The Regents of the University of Colorado

Aurora, Colorado, 80045, United States

Location

New York University School of Medicine

New York, New York, 10002, United States

Location

The Trustees of Columbia University in the City of New York

New York, New York, 10032, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

To collect blood and urine samples for future research to identify biomarkers specific to systemic lupus erythematosus and to LN.

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: June 7, 2017
• Study Start: March 13, 2018
• Primary Completion: September 25, 2020
• Study Completion: October 2, 2020
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)