PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT07611214
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LUPKYNIS — DRUG
    voclosporin
  • belimumab, obinutuzumab or anifrolumab — BIOLOGICAL
    BENLYSTA (belimumab), GAZYVA (obinutuzumab) or SAPHNELO (anifrolumab)
  • mycophenolic acid analog (MPAA) — DRUG
    CELLCEPT (mycophenolate mofetil \[MMF\]) or MYFORTIC (mycophenolic acid \[MPA\])
  • corticosteroid — DRUG
    prednisone (or equivalent)

Study Details

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).

Key Dates

Start date
Apr 22, 2026
Status verified
May 2026
Primary completion
Mar 2, 2029
Completion
Mar 2, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
    Patients will also receive concomitant mycophenolic acid analog and corticosteroids.

Primary Outcome Measure

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 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Valerius Medical Group & Research Center of Greater Long Beach, Inc.Los AlamitosCalifornia90720
Aurinia Clinical Trials Information
833-606-5975
Swati Shah MD Rheumatology, LLCJacksonvilleFlorida32257
Aurinia Clinical Trials Information
833-606-5975
CTR OakwaterOrlandoFlorida32806
Aurinia Clinical Trials Information
833-606-5975
Accurate Clinical Research, Inc.Lake CharlesLouisiana70605
Aurinia Clinical Trials Information
833-606-5975
Arthritis and Osteoporosis Consultants of the CarolinasCharlotteNorth Carolina28202
Aurinia Clinical Trials Information
833-606-5975
Joint and Muscle Research InstituteCharlotteNorth Carolina28204
Aurinia Clinical Trials Information
833-606-5975
West Tennessee Research InstituteJacksonTennessee38305
Aurinia Clinical Trials Information
833-606-5975
Liberty Research CenterDallasTexas75230
Aurinia Clinical Trials Information
833-606-5975
Texas Rheumatology Research Institute, LLCPlanoTexas75024
Aurinia Clinical Trials Information
833-606-5975
Nephrology Leaders and Associates, PLLCVan VleckTexas77482
Aurinia Clinical Trials Information
833-606-5975

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