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New treatment option for Lupus Nephritis
Official title PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
ClinicalTrials.gov ID: NCT07611214
What this study is testing
What is LUPKYNIS?
LUPKYNIS is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
- 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:
You likely can't join if
- Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration...
- 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...
- 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)
See the full eligibility 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 Key
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- Los Alamitos, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Lawrenceville, Georgia, United States
- Lake Charles, Louisiana, United States
- Charlotte, North Carolina, United States
- Jackson, Tennessee, United States
- Bellaire, Texas, United States
- Dallas, Texas, United States
- Harlingen, Texas, United States
- Houston, Texas, United States
- Plano, Texas, United States
- Van Vleck, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; Los Alamitos, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Lawrenceville, Georgia, United States; Lake Charles, Louisiana, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.