DIVINE: Dynamic Imaging of Variation in Lupus Nephritis

Sponsor

RILITE Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT03180021

Collaborator

(none)

Enrollment

Locations

30.7

Actual Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	Procedure: MRI

Study Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Dynamic Imaging of Variation in Lupus Nephritis

Actual Study Start Date :

Mar 13, 2018

Actual Primary Completion Date :

Sep 25, 2020

Actual Study Completion Date :

Oct 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients with Lupus Nephritis	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.
Patients with IgA Neuropathy	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.

Arm

Intervention/Treatment

Patients with Lupus Nephritis

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.

Patients with IgA Neuropathy

Procedure: MRI

Outcome Measures

Primary Outcome Measures

Diffusion Weight Imaging [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Regents of the University of Colorado	Aurora	Colorado	United States	80045
2	New York University School of Medicine	New York	New York	United States	10002
3	The Trustees of Columbia University in the City of New York	New York	New York	United States	10032
4	Ohio State University	Columbus	Ohio	United States	43210
5	Medical University of South Carolina	Charleston	South Carolina	United States	29425
6	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

RILITE Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RILITE Foundation

ClinicalTrials.gov Identifier:

NCT03180021

Other Study ID Numbers:

RIL-001

First Posted:

Jun 7, 2017

Last Update Posted:

Oct 4, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nephritis

Lupus Nephritis

Study Results

No Results Posted as of Oct 4, 2021