Safety and EfficacY of CombinatioN Belimumab and Voclosporin in the TrEatment of PRoliferative Forms of Lupus Glomerulopathy: Synergy Trial
NephroNet, Inc.
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.
Description
Lupus nephritis (LN) is the most serious common manifestation of systemic lupus erythematosus (SLE) and will ultimately affect about half of patients with SLE. LN increases the morbidity and mortality of patients with SLE, especially if Chronic Kidney Disease (CKD) and end-stage kidney disease (ESKD) develop. Morbidity and mortality are significantly mitigated if treatment-induced complete remission (CR) is achieved. While partial remission (PR) is better than no remission, its impact on renal survival is much less than CR. Within the last two years VCS and BEL have been approved for the treat…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed Informed Consent Form 2. Age 18-80 years at time of signing Informed Consent Form 3. Ability to comply with the study protocol, in the investigator's judgment 4. 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) • At least one positive ANA defined as a \>1:80 titer or a positive anti-ds-DNA within the last 3 years will be accepted. 5. ISN/RPS 2003 Class III, Class IV, Class III/V or Class IV/V Lupus Nephritis diagnos…
Interventions
- DrugVoclosporin
The trial is an open label, parallel, randomized study with patients randomized 1:1 the EARLY MMF TERMINATION (90 days) ARM or the EXTENDED MMF (360 days) ARM looking at the addition of Voclosporin in patients with Lupus Nephritis taking Belimumab, MMF, and Prednisone.
Locations (7)
- AARA Clinical ResearchGlendale, Arizona
- Piedmont Physicians RheumatologyAtlanta, Georgia
- Georgia Nephrology Research InstituteLawrenceville, Georgia
- Parris & AssociatesLawrenceville, Georgia
- Nephrology Clinical Trials Unit The Ohio State University Wexner Medical CenterColumbus, Ohio
- Oklahoma Medical Research FoundationOklahoma City, Oklahoma