Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Fo… (NCT07225387) | Clinical Trial Compass
RecruitingPhase 4
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
United States30 participantsStarted 2024-10-01
Plain-language summary
This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil (MMF), improves the proportion of patients with proliferative lupus nephritis achieving complete renal response (CRR) compared to proportion of patients achieving CRR from recent clinical trials. This protocol will additionally determine whether combination therapy using Belimumab (BEL) and Voclosporin (VCS) facilitates rapid discontinuation of MMF.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed Consent Form
. Age 18-80 years at time of signing Informed Consent Form
. Ability to comply with the study protocol, in the investigator's judgment
. A diagnosis of SLE by any one of the following criteria: European League Against Rheumatism/ American College of Rheumatology/Systemic Lupus International Collaborating Clinics (EULAR/ACR/SLICC)
. ISN/RPS 2003 Class III, Class IV, Class III/V or Class IV/V Lupus Nephritis diagnosed and meet one of these criteria:
. UPCR must be \>750 mg/gm from a 24 hour urine collection during screening. If the UPCR does not exceed 750 mg/gm, it may be repeated once during the screening period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome Measure: Day 360 (12 Month) Outcome
. Resting systolic blood pressure \<150 mm Hg and resting diastolic blood pressure \<90 mm Hg.
. Subject must be on maximum tolerated ACEi or ARB therapy as adjudicated by the site PI for ≥4 weeks prior to randomization.
Exclusion criteria
. Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
. Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized. 9. Positive human immunodeficiency virus (HIV) infection. 10. In the opinion of the Investigator, clinically significant drug or alcohol abuse 2 years prior to screening.