Lupus and Kidney Disease Research Study
Researchers at the University of California San Francisco are conducting a study to evaluate possible treatment options for individuals diagnosed with lupus nephritis (LN) and kidney disease.
Fast Facts
Ages 18+
Diagnosed with lupus
Compensation Provided
Conducted in San Francisco & San Mateo County
Study Background
Researchers from the University of California, San Francisco, are conducting a study to investigate study treatment options for those who have been diagnosed with lupus nephritis (LN).
The VIBRANT trial is exploring whether adding a new investigational treatment, VIB4920, to the standard therapy for lupus nephritis (LN) can provide better results than using standard treatment alone. This study aims to see if combining VIB4920 with the usual medications will offer improved benefits for managing LN.
VIB4920, also known as dazodilibep, is an innovative protein designed to block CD40L, which plays a role in the immune system’s attack on the body’s own tissues, including the kidneys. Initial trials in patients with rheumatoid arthritis have shown that VIB4920 is both safe and effective. Currently, it is being tested in other studies for different conditions. However, it is still considered an experimental treatment, as it has not yet been approved for use in the U.S. or any other country for any medical condition, including lupus nephritis.
We invite you to participate in this compensated study and contribute to advancing treatment options for lupus nephritis.
Study Background
Researchers from the University of California, San Francisco, are conducting a study to investigate study treatment options for those who have been diagnosed with lupus nephritis (LN).
The VIBRANT trial is exploring whether adding a new investigational treatment, VIB4920, to the standard therapy for lupus nephritis (LN) can provide better results than using standard treatment alone. This study aims to see if combining VIB4920 with the usual medications will offer improved benefits for managing LN.
VIB4920, also known as dazodilibep, is an innovative protein designed to block CD40L, which plays a role in the immune system’s attack on the body’s own tissues, including the kidneys. Initial trials in patients with rheumatoid arthritis have shown that VIB4920 is both safe and effective. Currently, it is being tested in other studies for different conditions. However, it is still considered an experimental treatment, as it has not yet been approved for use in the U.S. or any other country for any medical condition, including lupus nephritis.
We invite you to participate in this compensated study and contribute to advancing treatment options for lupus nephritis.
Additional Information
The VIBRANT trial aims to find out if adding experimental treatment VIB4920 to the standard treatment for lupus nephritis (LN) improves outcomes compared to using only standard therapy. This study will help determine if the combination therapy offers greater benefits than the current standard approach alone.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 18+
- Diagnosed with lupus
- Have active lupus nephritis (LN) (based on the amount of protein in your urine, and the results of your kidney biopsy within 24 weeks before or at the screening visit)
- Willing to use a reliable form of birth control during the duration of the study
Exclusion Criteria:
- Have had a tumor in the past year
- Currently on dialysis
- Have received an organ transplant
- Have been diagnosed, treated for, or tested positive for tuberculosis, HIV, hepatitis B virus (HBV), or hepatatis C virus (HCV)
- Currently pregnant or breastfeeding
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- Receive Standard Treatments: You will start with standard treatments for lupus nephritis, including intravenous (IV) methylprednisolone and oral mycophenolate mofetil (MMF). For the first 8 weeks, you will also take prednisone, which will be gradually reduced.
- Random Assignment: Participants will be randomly assigned to either the VIB4920 or placebo. You cannot choose which group you are in; this assignment is determined by a computer.
- Treatment Administration:
- You will receive VIB4920 or placebo via IV at Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
- You will also have a study visit in Week 1, which will not include an infusion.
- Ongoing Medication: Throughout the study, you will continue taking MMF and prednisone as part of your treatment regimen.
- Kidney Biopsy: Between Weeks 36 and 48, a kidney biopsy will be recommended, but it is not required. You and your study doctor will decide together if you will have this biopsy.
- Follow-Up Visits: You will attend follow-up study visits at Weeks 28, 32, 36, 48, and 60 to monitor your progress and response to the treatment.
You will be paid a total of $2,380 if you complete all study visits. The payments will be paid by check from the accounting services at the University of California San Francisco (UCSF). The payments will be made quarterly.
If you withdraw from the study, you will be paid only for the portions of the protocol study visits that you have completed.
There is no cost for you to participate in our research study.