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Dynamic Imaging of Variation in Lupus Nephritis (DIVINE)

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ClinicalTrials.gov Identifier: NCT03180021
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
RILITE Foundation

Tracking Information
First Submitted Date April 28, 2017
First Posted Date June 7, 2017
Last Update Posted Date January 14, 2021
Actual Study Start Date March 13, 2018
Actual Primary Completion Date October 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2017)
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dynamic Imaging of Variation in Lupus Nephritis
Official Title Dynamic Imaging of Variation in Lupus Nephritis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
To collect blood and urine samples for future research to identify biomarkers specific to systemic lupus erythematosus and to LN.
Sampling Method Non-Probability Sample
Study Population Patients with Lupus Nephritis or IgA neuropathy selected at academic sites listed.
Condition Lupus 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.

Study Groups/Cohorts
  • Patients with Lupus Nephritis
    Intervention: Procedure: MRI
  • Patients with IgA Neuropathy
    Intervention: Procedure: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 18, 2019)
21
Original Estimated Enrollment
 (submitted: June 6, 2017)
30
Estimated Study Completion Date December 2021
Actual Primary Completion Date October 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03180021
Other Study ID Numbers RIL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party RILITE Foundation
Study Sponsor RILITE Foundation
Collaborators Not Provided
Investigators Not Provided
PRS Account RILITE Foundation
Verification Date January 2021