PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
NCT07611214 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-05-28
Summary
The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).
Conditions
Interventions
- DRUG
-
LUPKYNIS
voclosporin
- BIOLOGICAL
-
belimumab, obinutuzumab or anifrolumab
BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
- DRUG
-
mycophenolic acid analog (MPAA)
CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])
- DRUG
-
prednisone (or equivalent)
Sponsors & Collaborators
-
Aurinia Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-22
- Primary Completion
- 2029-03-02
- Completion
- 2029-03-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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