🏛️ Verified NIH Record • Updated 2025-11-04
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial (NCT07225387)
🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: NephroNet, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (3 items).
Location: AARA Clinical Research — Glendale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: 1\. Currently on renal replacement therapy (dialysis or a kidney transplant), has had dialysis within 3 months of screening or is expected to require renal replacement therapy within 6 months of screening 2. Received cyclophosphamide within 12 weeks of study drug administration 3. Has received treatment with any of the following prior to screening: a) Rituximab or Obinutuzumab within 24 weeks of screening and there is no measure of circulating C19 B cells. If the measure of circulating C19 B cells is over 10%, the subject will be eligible for study participation. b) Use of Atacicept, BION-1301, Sibeprenlimab, Povetacicept, or other agents, with the exception of Belimumab, that directly inhibit B call activating factor (BAFF) and/or a proliferation inducing ligand (APRIL) within 12 weeks of study screening. 4\. Use of High dose Human Immunoglobulin therapy, abatacept, adalimumab, infliximab, certolizumab, etanercept, golimumab, anakinra, canakinumab, tocilizumab, sarilumab, Satralizumab, Ustekinumab, and Anifrolumab within 12 weeks of study screening. 5\. Pure Class V LN on biopsy. 6. In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids). 7\. Any known hypersensitivity or contraindication to MMF, MPA, Cyclosporine, Tacrolimus, Voclosporin Corticosteroids, Belimumab or any components of these drug products. 8\. Current or medical history of:
- 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. 11\. Known malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas of the skin Note: Subjects with cervical dysplasia that is CIN1, but have been treated with conization or LEEP, and have had a normal repeat PAP are allowed. 12: Lymphoproliferative disease or previous total lymphoid irradiation. 13. Known viral infection (such as HBV and HCV) within 3 months of screening. If HBC and HCV status is unknown, testing should be performed during screening. Subjects with past medical history of HBC or HCV exposure with positive antibodies may be enrolled if a DNA PCR test was negative. 14\. Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. QuantiFERON gold test must be negative at screening or subject taking isoniazid. Note: If positive at screening the subject can be screen failed, treated, and rescreened in 4 weeks with a confirmed negative chest x-ray. 15\. Patients with known "poor intravenous access" WILL be allowed to participate having placement of a "passport",or port, central IV access or its equivalent for subjects requiring IV infusions of Belimumab upon review and approval by the Medical Monitor 16. Other known clinically significant active medical conditions, such as: a) Severe cardiovascular disease, including congestive heart failure b) history of cardiac dysrhythmia or congenital long QT syndrome. QTcF (QT interval duration corrected for heart rate using method of Fridericia) exceeding 480 msec in the presence of a normal QRS interval (\<110 msec) on historic ECG, if available. An ECG is not is not required for study entry. 17\. Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than 2.5 times the upper limit of normal) at screening. \-
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- AARA Clinical Research — Glendale, Arizona
- Piedmont Physicians Rheumatology — Atlanta, Georgia
- Georgia Nephrology Research Institute — Lawrenceville, Georgia
- Parris & Associates — Lawrenceville, Georgia
- Nephrology Clinical Trials Unit The Ohio State University Wexner Medical Center — Columbus, Ohio
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma
- AARA Clinical Research — Fort Worth, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.