Actively Recruiting
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
Led by NephroNet, Inc. · Updated on 2025-11-06
30
Participants Needed
7
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 to 80 years at time of consent
- Ability to comply with study protocol
- Diagnosis of SLE by EULAR/ACR/SLICC criteria with positive ANA (>1:80) or anti-ds-DNA within last 3 years
- ISN/RPS 2003 Class III, IV, III/V, or IV/V lupus nephritis diagnosed with current or recent biopsy
- Urine protein to creatinine ratio (UPCR) >750 mg/gm in screening urine collection
- Resting blood pressure less than 150/90 mm Hg (with allowance for repeat measurements)
- On maximum tolerated ACE inhibitor or ARB therapy for at least 4 weeks prior to randomization
- Stable dose of other protein-lowering agents (e.g., calcium channel blockers, SGLT2 inhibitors, MRAs) for at least 4 weeks prior to randomization
- Estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 for biopsies older than 3 months; eGFR >20 ml/min/1.73m2 for recent biopsies with specific conditions
- Adequate blood counts: neutrophils ≥1.5 × 10^9/L, lymphocytes ≥1.0 × 10^9/L, platelets >75 × 10^9/L, hemoglobin >8.5 g/dL
- Taking Belimumab prior to screening or willing to start at baseline
- Women of childbearing potential must use highly effective contraception consistently and correctly throughout the study
You will not qualify if you...
- Currently on or expected to require renal replacement therapy within 6 months
- Received cyclophosphamide within 12 weeks before study drug
- Prior treatment with certain B-cell targeting agents or immunosuppressants within specified timeframes
- Pure Class V lupus nephritis on biopsy
- Investigator opinion that long-term immunosuppressive treatment is not needed
- Known allergies or contraindications to study drugs
- Recent pancreatitis, gastrointestinal hemorrhage, or active peptic ulcer
- Positive HIV infection
- Significant drug or alcohol abuse within 2 years
- Known malignancy within 5 years except treated skin cancers and certain cervical conditions
- Lymphoproliferative disease or prior total lymphoid irradiation
- Recent viral infections (e.g., HBV, HCV) unless controlled
- Active or untreated tuberculosis
- Severe cardiovascular disease or significant ECG abnormalities
- Liver dysfunction with elevated liver enzymes or bilirubin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
AARA Clinical Research
Glendale, Arizona, United States, 85306
Actively Recruiting
2
Piedmont Physicians Rheumatology
Atlanta, Georgia, United States, 30318
Actively Recruiting
3
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
4
Parris & Associates
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
5
Nephrology Clinical Trials Unit The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43201
Actively Recruiting
6
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
7
AARA Clinical Research
Fort Worth, Texas, United States, 76109
Actively Recruiting
Research Team
J
Jeremy Whitson
CONTACT
J
Julie Scoggin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here