Dynamic Imaging of Variation in Lupus Nephritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Regents of the University of Colorado, Aurora, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).
Pregnant or nursing females, or females not using effective contraception.
Inability or unwillingness to return to the research site clinic for study visits at baseline and at 6 months.

Treatment and study plan

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.

Primary outcomes

Diffusion Weight Imaging

Time frame: 7 Months

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.
Blood Oxygen Level Dependent Imaging

Time frame: 7 Months

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.
T1rho Imaging

Time frame: 7 Months

T1rho (T1rho) imaging is an MRI technique that is sensitive to the presence of macromolecules, such as collagen and proteoglycan 13.
Dynamic Contrast Enhanced Magnetic Resonance Imaging

Time frame: 7 Months

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).

Sponsors and collaborators

Lead sponsor

RILITE Foundation

Other

Registry information

Acronym: DIVINE

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jun 7, 2017
Registry last updated: Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed