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

ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAurinia Pharmaceuticals Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)

Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)

Trial design

Design model

Single group

Treatments tested in this trial

  • LUPKYNIS

    Drug

    voclosporin

  • belimumab, obinutuzumab or anifrolumab

    Biological/Vaccine

    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)

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aurinia Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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