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VIB4920 for Lupus Nephritis (VIBRANT Trial)
Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Classification of Systemic Lupus Erythematosus (SLE) by specified criteria
Age 18 years or older
Must not have
Unwillingness to use a medically acceptable form of contraception
Prior treatment with VIB4920
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12, 24, 36, 48 and 60
Summary
This trial is testing a new drug called VIB4920, along with two other medications, MMF and prednisone, to treat kidney problems caused by lupus. The study involves people who have active lupus nephritis, a serious kidney condition. The treatment aims to reduce inflammation and calm the immune system to help improve kidney function. MMF has been established as an effective treatment for lupus nephritis, often used in combination with other medications like prednisone.
Who is the study for?
This trial is for adults over 18 with active lupus nephritis, diagnosed by specific criteria and a recent kidney biopsy. Participants must have had a COVID-19 vaccine as per CDC guidelines. Those with substance abuse history, certain infections like HIV or tuberculosis, past significant infections, or on treatments like biologics (except belimumab) are excluded.
What is being tested?
The VIBRANT study tests the effectiveness of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in treating lupus nephritis compared to a placebo. This double-blind study means neither participants nor researchers know who's receiving the real treatment versus the placebo.
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible drug-specific adverse effects which could range from mild symptoms like nausea to more serious conditions depending on individual health factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Systemic Lupus Erythematosus.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unwilling to use birth control.
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I have previously been treated with VIB4920.
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I frequently get serious infections.
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I have had tuberculosis in the past or have it now.
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I do not have any ongoing serious infections.
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I have or had hepatitis B.
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I have or had hepatitis C.
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I am HIV positive.
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I cannot take MMF or mycophenolate sodium due to health reasons.
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I am being treated with steroids for another health condition.
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My kidneys are in the final stage of failure.
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I have a history of cancer, but it may fit exceptions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12, 24, 36, 48 and 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 24, 36, 48 and 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants achieving a complete renal response at week 36
Secondary study objectives
Anti-dsDNA antibodies
Change in Serum IgG over study participation
Change in Serum IgM over study participation
+11 moreSide effects data
From 2023 Phase 2 trial • 25 Patients • NCT0404654922%
COVID-19
17%
Anaemia
17%
Leukopenia
17%
BK virus infection
17%
Hypophosphataemia
13%
Arthralgia
13%
Headache
9%
Neutropenia
9%
Urinary tract infection
9%
Procedural pain
9%
Post procedural urine leak
9%
Hypokalaemia
9%
Metabolic acidosis
9%
Pain in extremity
9%
Insomnia
4%
Clostridium difficile infection
4%
Urosepsis
4%
Ileus
4%
Cholecystitis acute
4%
Kidney transplant rejection
4%
Bacteraemia
4%
Diabetic foot infection
4%
Cytomegalovirus test positive
4%
Hypervolaemia
4%
Depression suicidal
4%
Subcapsular renal haematoma
4%
Ureteric stenosis
4%
Arteriovenous fistula site complication
4%
Blood creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept+VIB4920
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VIB4920Experimental Treatment1 Intervention
Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.
Group II: VIB4920 PlaceboPlacebo Group1 Intervention
Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Participants will also receive methylprednisolone 1000 mg at Week 0 and will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to ≤ 5 mg per day from Week 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIB4920
2019
Completed Phase 2
~350
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Lupus Nephritis, such as mycophenolate mofetil (MMF) and prednisone, work by suppressing the immune system to reduce inflammation and prevent immune-mediated damage to the kidneys. MMF inhibits the proliferation of T and B lymphocytes, which are crucial in the autoimmune response, while prednisone is a corticosteroid that reduces inflammation by inhibiting multiple inflammatory pathways.
VIB4920, which is being studied in clinical trials, inhibits the CD40-CD40L interaction, a critical pathway in the activation of immune cells. This inhibition can potentially reduce the immune system's attack on kidney tissues, thereby decreasing inflammation and preventing further kidney damage.
These mechanisms are vital for Lupus Nephritis patients as they help preserve kidney function and improve long-term outcomes.
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,330 Previous Clinical Trials
5,366,758 Total Patients Enrolled
4 Trials studying Lupus Nephritis
187 Patients Enrolled for Lupus Nephritis
Betty Diamond, M.D.Study ChairFeinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
1 Previous Clinical Trials
43 Total Patients Enrolled
1 Trials studying Lupus Nephritis
43 Patients Enrolled for Lupus Nephritis
Maria Dall'Era, M.D.Study ChairUniversity of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
1 Previous Clinical Trials
43 Total Patients Enrolled
1 Trials studying Lupus Nephritis
43 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Systemic Lupus Erythematosus.I am unwilling to use birth control.I have previously been treated with VIB4920.I haven't taken any biologic treatment recently, except for belimumab.You are currently using drugs or have used drugs in the past year.I frequently get serious infections.I have not received a live vaccine in the last 4 weeks.You had a kidney biopsy within the last 24 weeks and it showed specific criteria.You don't have a vein that can be used for taking blood from your arm.I have not received Rituximab or similar treatments in the last 6 months.I am at risk for blood clots.I have had tuberculosis in the past or have it now.I do not have any ongoing serious infections.I have or had hepatitis B.You have any of the listed abnormal test results.Your UPCR (urine protein-to-creatinine ratio) is higher than 1.0 based on a 24-hour urine collection before the study starts.You have had a serious mental health condition in the past.You have had an organ or tissue transplant in the past.I have or had hepatitis C.I am HIV positive.I have other health issues not mentioned here.I cannot take MMF or mycophenolate sodium due to health reasons.I am 18 years old or older.I am being treated with steroids for another health condition.My kidneys are in the final stage of failure.I have a history of cancer, but it may fit exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: VIB4920
- Group 2: VIB4920 Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.