PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
Purpose
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).
Condition
- Lupus Nephritis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab |
Patients will also receive concomitant mycophenolic acid analog and corticosteroids. |
|
Recruiting Locations
Purushotham & Akther Kotha MD, Inc.
La Mesa, California 91942
La Mesa, California 91942
Valerius Medical Group & Research Center of Greater Long Beach, Inc.
Los Alamitos, California 90720
Los Alamitos, California 90720
Swati Shah MD Rheumatology, LLC
Jacksonville, Florida 32257
Jacksonville, Florida 32257
CTR Oakwater
Orlando, Florida 32806
Orlando, Florida 32806
Parris and Associates Rheumatology
Lawrenceville, Georgia 30044
Lawrenceville, Georgia 30044
Accurate Clinical Research, Inc.
Lake Charles, Louisiana 70605
Lake Charles, Louisiana 70605
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina 28202
Charlotte, North Carolina 28202
Joint and Muscle Research Institute
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
West Tennessee Research Institute
Jackson, Tennessee 38305
Jackson, Tennessee 38305
Novel Research LLC
Bellaire, Texas 77401
Bellaire, Texas 77401
Liberty Research Center
Dallas, Texas 75230
Dallas, Texas 75230
Integrative Rheumatology of South Texas
Harlingen, Texas 78550
Harlingen, Texas 78550
Northwest Houston Arthritis Center
Houston, Texas 77090
Houston, Texas 77090
Texas Rheumatology Research Institute, LLC
Plano, Texas 75024
Plano, Texas 75024
Nephrology Leaders and Associates, PLLC
Van Vleck, Texas 77482
Van Vleck, Texas 77482
More Details
- Status
- Recruiting
- Sponsor
- Aurinia Pharmaceuticals Inc.
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).