Last reviewed · How we verify
Safety and EfficacY of CombinatioN Belimumab and Voclosporin in the TrEatment of PRoliferative Forms of Lupus Glomerulopathy: Synergy Trial (SYNERGY)
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.
Details
| Lead sponsor | NephroNet, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2024-10-01 |
| Completion | 2027-01 |
Conditions
- Lupus Nephritis
Interventions
- Voclosporin
Primary outcomes
- Primary Outcome Measure: Day 360 (12 Month) Outcome — 12 months
Proportion of Patients achieving and maintaining a Complete Clinical Renal Remission (CCRR) at 12 months. CCRR is defined as: UPCR≤ 0.5, eGFR≥60 and not \>20% below baseline, no rescue meds, sustained on repeat assessment 30 days later.
Countries
United States