ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 146 for:    lupus AND Lupus Nephritis

Dynamic Imaging of Variation in Lupus Nephritis (DIVINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03180021
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
RILITE Foundation

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
Lupus Nephritis Procedure: MRI

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dynamic Imaging of Variation in Lupus Nephritis
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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.





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Lupus Nephritis or IgA neuropathy selected at academic sites listed.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180021


Contacts
Contact: Claire Dykas 434-977-2675 claire.dykas@ampelbiosolutions.com

Locations
United States, Colorado
The Regents of the University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan Boackle    303-724-7611    susan.boackle@ucdenver.edu   
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10002
Contact: Amit Saxena    646-501-7400    amit.saxena@nyumc.org   
The Trustees of Columbia University in the City of New York Recruiting
New York, New York, United States, 10032
Contact: Anca Askanase    212-305-0856    ada20@cumc.columbia.edu   
United States, North Carolina
University of North Carolina Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Manish Saha    919-445-2631    manish_saha@med.unc.edu   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Brad Rovin    614-293-4997    brad.rovin@osumc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Eric Zollars    843-792-1964    zollars@musc.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David Karp    214-648-9110    david.karp@utsouthwestern.edu   
Sponsors and Collaborators
RILITE Foundation

Responsible Party: RILITE Foundation
ClinicalTrials.gov Identifier: NCT03180021     History of Changes
Other Study ID Numbers: RIL-001
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases