Recruiting NCT07611214
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LUPKYNIS, belimumab, obinutuzumab or anifrolumab, mycophenolic acid analog (MPAA), corticosteroid.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis
Overview
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).
Detailed description
Patients with LN will be administered LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab. Additionally, patients will receive treatment with a mycophenolic acid analog (MPAA), specifically mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and oral prednisone (or equivalent).
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 corticosteroid
prednisone (or equivalent)
Primary outcome measures
- To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with complete renal response at 24 weeks [Time frame: 24 weeks]
Secondary outcome measures (8)
- To assess the safety of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Incidence of treatment-emergent adverse events [Time frame: From baseline to study completion, up to 28 weeks]
- To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with partial renal response at 24 weeks [Time frame: 24 weeks]
- To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with deep renal response rate at 24 weeks [Time frame: 24 weeks]
- To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to complete renal response [Time frame: From baseline to complete renal response, up to 24 weeks]
- To assess the time to reach efficacy endpoints of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Time to partial renal response [Time frame: From baseline to partial renal response, up to 24 weeks]
- To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of anti-double-stranded deoxyribonucleic acid (dsDNA) autoantibodies at 12 weeks and at 24 weeks [Time frame: Baseline, 12 weeks, and 24 weeks]
- To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 3 (C3) at 12 weeks and at 24 weeks [Time frame: Baseline, 12 weeks, and 24 weeks]
- To investigate the pharmacodynamics of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab: Change from baseline in levels of complement 4 (C4) at 12 weeks and at 24 weeks [Time frame: Baseline, 12 weeks, and 24 weeks]
Eligibility criteria
Inclusion criteria
- Adults 18-75 years old
- Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V)
- Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and <5.0 g/g from a first morning void (FMV) urine sample
- Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2
- Concomitant biologic:
- Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1.
- Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening.
- Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1
- Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \[or equivalent\]) or by initiating on or before Day 1
Exclusion criteria
- Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range
- Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening
- Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \[or equivalent\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening:
- Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)
- Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)
- T cell costimulation modulator (eg, abatacept)
- Intravenous immunoglobulin (IVIg)
- Janus kinase (JAK) inhibitors (eg, upadacitinib)
- Pregnant, breastfeeding or intending to become pregnant during the Study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 27 centers
- Purushotham & Akther Kotha MD, Inc. — La Mesa
- Valerius Medical Group & Research Center of Greater Long Beach, Inc. — Los Alamitos
- Western Nephrology & Metabolic Bone Disease, PC — Arvada
- Swati Shah MD Rheumatology, LLC — Jacksonville
- Vida Clinical Research — Kissimmee
- Life Clinical Trials — Margate
- CTR Oakwater — Orlando
- Parris and Associates Rheumatology — Lawrenceville
- … and 19 more centers
Identifiers
NCT: NCT07611214 · AUR-VCS-2025-01