Clinical trial 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 being studied to see if it helps treat lupus nephritis when taken with other drugs. It is designed to block a specific protein called calcineurin to help reduce inflammation in the kidneys.
Also referred to as voclosporin.
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
- This study checks if combining Lupkynis with other lupus treatments helps kidneys heal quickly and safely.
- Who it's for
- People who have lupus nephritis, which is kidney damage caused by lupus.
- What's involved
- Participants will take Lupkynis along with one of three other lupus medicines and undergo regular health checks.
- Time commitment
- The study duration and specific visit schedule are not listed in the provided text.
- 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
- Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will...
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
- 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)
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
- 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
- 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 is enrolling
- La Mesa, California, United States
- Los Alamitos, California, United States
- Arvada, Colorado, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Margate, Florida, United States
- Orlando, Florida, United States
- Lawrenceville, Georgia, United States
- Lake Charles, Louisiana, United States
- Rockville, Maryland, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
- West Long Branch, New Jersey, United States
- Orchard Park, New York, United States
- Charlotte, North Carolina, United States
- Willow Grove, Pennsylvania, United States
- Dakota Dunes, South Dakota, United States
- Jackson, Tennessee, United States
- Bellaire, Texas, United States
- Dallas, Texas, United States
+ 6 more site(s).
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, but 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?
This study is enrolling now at La Mesa, California, United States; Los Alamitos, California, United States; Arvada, Colorado, United States; Jacksonville, Florida, United States; Kissimmee, Florida, United States; Margate, Florida, United States and 20 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.