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The DIVERT Study

A new medication, Voclosporin, has been approved to treat lupus in the kidneys (lupus nephritis). We want to learn if this new medicine is the same or better at treating lupus outside the kidney (SLE) than the currently available medicine (Mycophenolate Mofetil). This is especially important because lupus symptoms can vary and the medicine that helps each person best can be different. In this study, we want to understand who would benefit most from one medicine, or the other, or maybe even both together.

Age & Gender

  • 18 years ~ 60 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At each visit you will meet with a member of the study team and fill out questionnaires, get labs done, and have a physical exam. The study also involves ECG measurements and a willingness to take the study medication regularly. You will need to stop all lupus medications for one month before you get study treatment. The study physician will give you steroids to manage your symptoms during this time.

Incentives

Up to $850, Study medication at no cost

In-person visits:
1-28
Total length of participation:
13-14 months

Looking for Specific Volunteers

Able to participate:

  • Current diagnosis of Systemic Lupus Erythematosus (SLE)
  • Willing to use reliable method of contraception during the study
  • Vaccinated against COVID-19 and up to date on booster doses

Not eligible if:

  • Chronic and active infection of HIV, Hepatitis B, and Hepatis C.
  • Severe or unstable Nephritis Class 3-5 within the last 2 years
  • History of cirrhosis or chronic liver disease unrelated to SLE
  • Unwilling or unable to reduce the use of prednisone to lower than 10 mg/day

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Secondary Visit Location

Rheumatology Outpatient Center
UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Saira Sheikh
Thurston Arthritis Research Center

Study Type

Clinical or Medical
Interventional

Study Topics

Bones, Joints, Muscles
Chronic Conditions
Immune System/Infections
Minority Health
Rare Diseases
Women's Health

IRB Number

22-2908

ClinicalTrials.gov

NCT05306873

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Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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