Your session is about to expire
← Back to Search
Monoclonal Antibodies
Belimumab + Rituximab for Kidney Disease (REBOOT Trial)
Phase 2
Waitlist Available
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
Serum anti-PLA2R positive
Proteinuria ≥ 4 and < 8 g/day that has persisted for at least the previous 3 months while on maximally tolerated RAS blockade
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 156 weeks (3 years)
Awards & highlights
REBOOT Trial Summary
This trial will enroll approximately 30 participants with primary MN who are not well controlled with their current therapy. Participants will be randomly assigned (by chance, like flipping a coin) to one of two treatment groups.
Who is the study for?
Adults aged 18-75 with primary membranous nephropathy, confirmed by kidney biopsy within the last 5-7 years, and experiencing significant protein loss in urine despite treatment. Participants must have a stable kidney function and blood pressure under control. They should be vaccinated against COVID-19 as per CDC guidelines. Pregnant or breastfeeding women, recent recipients of certain immunosuppressants or live vaccines, and those with various health complications are excluded.Check my eligibility
What is being tested?
The trial is testing if belimumab combined with rituximab can induce complete remission in primary membranous nephropathy more effectively than rituximab alone. Belimumab may reduce new B cells that cause immune attacks on kidneys; neither drug is currently FDA-approved for this condition.See study design
What are the potential side effects?
Potential side effects include reactions to infusions, infections due to weakened immunity, blood cell count changes (like anemia), liver enzyme elevations indicating potential liver damage, allergic reactions to medication components, and possibly others not listed here.
REBOOT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood test is positive for anti-PLA2R antibodies.
Select...
I have had protein in my urine between 4 and 8 g/day for the last 3 months despite treatment.
Select...
My blood pressure is 140 or lower with my current medication.
Select...
I am losing more than 8 grams of protein a day in my urine despite taking medication.
Select...
I have nephrotic syndrome and cannot undergo a kidney biopsy.
Select...
My kidney function is adequate while on specific blood pressure medication.
Select...
My lowest blood pressure number is 90 or less, even with my current medication.
Select...
I am between 18 and 75 years old.
REBOOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 156 weeks (3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 156 weeks (3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants in Complete Remission (CR) at Week 104: By Treatment Group
Secondary outcome measures
Belimumab Exposure After the First 4 Doses of Belimumab
Incidence of Adverse Events (AEs): By Treatment Group
Incidence of Arterial Thromboembolic Events: By Treatment Group
+12 moreOther outcome measures
EXPLORATORY: Belimumab Levels at Week 4, Week 12, Week 24, Week 36 and Week 52
Side effects data
From 2018 Phase 3 trial • 80 Patients • NCT0211915636%
Nasopharyngitis
18%
Hypokalaemia
9%
Vertigo
9%
Ocular discomfort
9%
Gastroenteritis
9%
Cystitis
9%
Periodontal disease
9%
Joint injury
9%
Lumbar vertebral fracture
9%
Upper respiratory tract infection
9%
Dental caries
9%
Musculoskeletal chest pain
9%
Cough
9%
Otitis externa bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Phase: Treatment Holiday Group - Re-start Phase
Maintenance Phase: Treatment Holiday
Treatment Phase: Long-term Discontinuation Group
Treatment Phase: Treatment Control Group
Treatment Phase: Treatment Holiday Group - Holiday Phase
Maintenance Phase: Treatment Control
REBOOT Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Low Proteinuria Group - Belimumab and RituximabExperimental Treatment2 Interventions
Participants in the low proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive subcutaneous belimumab 400 mg (two 200 mg injections) once weekly from weeks 0-3, and then 200 mg once weekly from weeks 4-51. Participants will receive rituximab infusions at Weeks 4 and 6.
At week 30, participants will be assessed for a response to study treatment. Participants who meet at least two out of the following three criteria at week 30 will be considered to have an inadequate response to study treatment and receive a second course of rituximab (defined as 1000 mg IV given at weeks 34 and 36):
Anti-PLA2R level is ≥ 25% of baseline
Proteinuria is ≥ 50% of baseline
Serum albumin is < 2.8 g/dL
Group II: Part B :High Proteinuria Group - Belimumab and RituximabExperimental Treatment2 Interventions
Participants in the high proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive subcutaneous belimumab 400 mg (two 200 mg injections) once weekly from weeks 0-3, and then 200 mg once weekly from weeks 4-51. Participants will receive rituximab infusions at Weeks 4 and 6.
At week 30, participants will be assessed for a response to study treatment. Participants who meet at least two out of the following three criteria at week 30 will be considered to have an inadequate response to study treatment and receive a second course of rituximab (defined as 1000 mg IV given at weeks 34 and 36):
Anti-PLA2R level is ≥ 25% of baseline
Proteinuria is ≥ 50% of baseline
Serum albumin is < 2.8 g/dL
Group III: Part A: Low Proteinuria Group - Belimumab and RituximabExperimental Treatment2 Interventions
Open-label pharmacokinetics (PK) phase.
Participants with low proteinuria classification will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.
Low proteinuria classification: The excretion of ≥4 to <8 g/day of protein by the kidneys in adults. (Normal in adults: 0.15 g/day).
Group IV: Part A :High Proteinuria Group - Belimumab and RituximabExperimental Treatment2 Interventions
Open-label pharmacokinetics (PK) phase.
Participants with high proteinuria classification will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.
High proteinuria classification: The excretion of ≥8 g/day of protein by the kidneys in adults. (Normal in adults: 0.15 g/day).
Group V: Part A :High Proteinuria Group - Placebo and RituximabPlacebo Group2 Interventions
Participants in the high proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive belimumab placebo weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.
Group VI: Part B: Low Proteinuria Group - Placebo and RituximabPlacebo Group2 Interventions
Participants in the low proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive subcutaneous belimumab placebo 400 mg (two 200 mg injections) once weekly from weeks 0-3, and then 200 mg once weekly from weeks 4-51. Participants will receive rituximab infusions at Weeks 4 and 6.
At week 30, participants will be assessed for a response to study treatment. Participants who meet at least two out of the following three criteria at week 30 will be considered to have an inadequate response to study treatment and receive a second course of rituximab (defined as 1000 mg IV given at weeks 34 and 36):
Anti-PLA2R level is ≥ 25% of baseline
Proteinuria is ≥ 50% of baseline
Serum albumin is < 2.8 g/dL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Belimumab
FDA approved
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,008 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,794 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,751 Previous Clinical Trials
8,067,348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition might have a specific cause based on my medical history.You have a positive QuantiFERON - TB Gold test.You have a positive HIV test.You are currently using drugs or alcohol excessively.You have a moderate form of anemia with low hemoglobin levels.My blood test is positive for anti-PLA2R antibodies.You currently have or have had a hepatitis B infection.I haven't taken any corticosteroids in the last 30 days.You have taken any experimental biologic drug in the last year.My kidney function has dropped by more than 20% in the last 3 months due to my kidney disease.Your white blood cell count is less than 3,000 per microliter.I have had protein in my urine between 4 and 8 g/day for the last 3 months despite treatment.My blood pressure is 140 or lower with my current medication.I am not pregnant, nursing, and willing to use contraception or abstain from sex until week 104.I have nephrotic syndrome, my kidney function is good, and I haven't taken immunosuppressants for it.I have not been hospitalized or used strong antibiotics for an infection in the last 60 days.I have hepatitis C but was successfully treated.Your blood test shows low levels of IgA.I am losing more than 8 grams of protein a day in my urine despite taking medication.Your protein levels in the urine have decreased by half or more in the past year.You have had a serious allergic reaction or are sensitive to certain substances.I used Rituximab over a year ago without achieving complete or partial remission, or my CD19 B cell count is undetectable.There is strong evidence that you may harm yourself.Your liver enzymes (ALT or AST) are more than double the normal levels.My kidney disease was confirmed by a biopsy in the last 5 years.You have a history of a weak immune system from birth.I haven't taken immunosuppressive drugs like cyclosporine or tacrolimus in the last 30 days.My kidney disease has come back after partial or complete improvement.I have not used Rituximab in the last 12 months.I have nephrotic syndrome and cannot undergo a kidney biopsy.My diabetes is not well-managed, with an HbA1c level of 9.0% or higher.My kidney function is adequate while on specific blood pressure medication.I am fully vaccinated against COVID-19 as per CDC guidelines, with my last dose received at least 14 days ago.My lowest blood pressure number is 90 or less, even with my current medication.I haven't had cancer in the last 5 years, except for skin cancer.I have lung disease with reduced lung function or need extra oxygen.I have not received a live vaccine in the last 30 days.My kidney biopsy shows I have advanced diabetic kidney damage.I haven't used any B cell therapy except rituximab in the last year.I have not taken Cyclophosphamide in the last 3 months.Your body has too few infection-fighting white blood cells.I have not had cancer screenings recommended for my age.I have been diagnosed with a specific condition.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Part B :High Proteinuria Group - Belimumab and Rituximab
- Group 2: Part A :High Proteinuria Group - Placebo and Rituximab
- Group 3: Part A: Low Proteinuria Group - Belimumab and Rituximab
- Group 4: Part A :High Proteinuria Group - Belimumab and Rituximab
- Group 5: Part B: Low Proteinuria Group - Belimumab and Rituximab
- Group 6: Part B: Low Proteinuria Group - Placebo and Rituximab
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Nephrotic Syndrome Patient Testimony for trial: Trial Name: NCT03949855 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this particular experiment be beneficial for elderly adults?
"This particular clinical trial is open to patients aged 18-75. Out of the 869 trials for seniors and 113 trials for minors, this one falls in the middle."
Answered by AI
How many people have the option to enroll in this trial at most?
"The clinical trial is currently enrolling patients, with the goal of signing up 124 individuals total. The study is hosted at 17 different facilities across the United States of America and was first posted on December 18th, 2019."
Answered by AI
Are there any patients needed for this research project?
"Yes, this study is still recruiting patients according to the latest information on clinicaltrials.gov. The trial was originally posted on December 18th, 2019 and was last updated on September 22nd, 2022. So far, 124 patients have been enrolled across 17 different locations."
Answered by AI
Do we have any other evidence to support the efficacy of Belimumab?
"The first study into the efficacy of belimumab was completed in 1993 at the National Institutes of Health Clinical Center. There have been 835 such studies conducted in total, with 434 active trials ongoing as of now. Many of these are based out of Spokane, Washington."
Answered by AI
Might I be able to take part in this clinical trial?
"This study is open to patients that have nephrotic syndrome and are between 18-75 years old. They aim to enroll 124 individuals in total."
Answered by AI
Are there any life-threatening risks associated with Belimumab?
"Belimumab's safety is not well-documented, as this medication is still in Phase 2 clinical trials. There is some evidence that it may be safe for human use, but no data confirming its efficacy."
Answered by AI
What condition is Belimumab most often prescribed to treat?
"Belimumab is indicated for the treatment of diffuse large b-cell lymphoma (dlbcl), as well as other conditions like b-cell lymphomas, polyangium, and pemphigus vulgaris."
Answered by AI
At how many different sites can participants enroll in this trial?
"This clinical trial is accepting patients at Providence Medical Research Center, Providence Health Care: Nephrology in Spokane, Washington, Stanford University School of Medicine: Division of Nephrology in Stanford, California, and The University of British Columbia: Division of Nephrology in Vancouver, British Columbia to name a few. There are 17 other locations where this trial is being conducted."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
California
Pennsylvania
What site did they apply to?
University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center
University of Pennsylvania: Department of Medicine: Renal-Electrolyte and Hypertension Division
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I also have dry mouth.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger