Clinical trials: SLE Nephritis
Lupus Nephritis
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g
This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months.
- Trial name
- NCT00404157
- Testing
- Rituximab
- Sponsor
- Genentech, Inc.
Lupus Nephritis
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and…
- Trial name
- LUMINA (NCT07053800)
- Testing
- Obecabtagene autoleucel
- Where
- 16 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited
Lupus Nephritis
The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids.
- Trial name
- NCT00573157
- Testing
- Atacicept, Mycophenolate mofetil, Corticosteroids
- Where
- 20 sites in United States, Czechia and 3 more
- Volunteers
- 6 people
- Sponsor
- EMD Serono
Systemic Lupus Erythematosus, Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
- Trial name
- NCT06121297
- Testing
- CABA-201
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 28 people
- Sponsor
- Cabaletta Bio
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).
- Trial name
- VOCAL (NCT05288855)
- Testing
- Voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 9 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Lupus Erythematosus, Systemic, Lupus Nephritis
Study of LJP 394 in Lupus Patients With History of Renal Disease
The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.
- Trial name
- ASPEN (NCT00089804)
- Testing
- abetimus sodium (LJP 394), Phosphate-buffered saline
- Where
- 201 sites in United States, Argentina and 28 more
- Volunteers
- 943 people
- Sponsor
- La Jolla Pharmaceutical Company
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
Lupus Nephritis, Systemic Lupus Erythematosus
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III
- Trial name
- RECLAIM-LN (NCT07570862)
- Testing
- FT819
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Fate Therapeutics
IgA Nephropathy, Lupus Nephritis (LN)
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy…
- Conditions
- IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy
- Trial name
- NCT06419205
- Testing
- ADX-097
- Where
- 4 sites in United States, Brazil
- Volunteers
- 30 people
- Sponsor
- Akebia Therapeutics
Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE)
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Lupus Nephritis Refractory to Standard Therapy
This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in…
- Conditions
- Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE), Autoimmune Diseases
- Trial name
- NCT07729826
- Testing
- C-CAR168
- Volunteers
- 50 people
- Sponsor
- AbelZeta Inc.
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Lupus Nephritis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with…
- Trial name
- POSTERITY (NCT05039619)
- Testing
- Obinutuzumab, Mycophenolate Mofetil, Acetaminophen/paracetamol
- Where
- 44 sites in United States, Brazil and 10 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis
LUPKYNIS Drug-use Results Survey
The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.
- Trial name
- NCT07053891
- Testing
- Voclosporin (LUPKYNIS)
- Where
- Japan
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Lupus Nephritis, Lupus Erythematosus, Systemic
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients
This study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE (systemic lupus erythematosus) and how…
- Trial name
- NCT04266860
- Testing
- Experimental - Test Results and Education
- Where
- United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Systemic Lupus Erythematosus (SLE)
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response…
- Trial name
- BENCHMARK-SLE (NCT07175285)
- Testing
- Current standard of care treatment options
- Where
- 70 sites in United States, Argentina and 11 more
- Volunteers
- 223 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
Study of LJP 394 (Abetimus Sodium) in Lupus Patients
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.
- Trial name
- NCT00390091
- Testing
- abetimus sodium (LJP 394)
- Where
- 2 sites in United States
- Sponsor
- La Jolla Pharmaceutical Company
Lupus Nephritis, Systemic Lupus Erythematosus
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant…
- Trial name
- BELONG (NCT00626197)
- Testing
- Corticosteroids, Cyclophosphamide, Mycophenolate Mofetil
- Volunteers
- 381 people
- Sponsor
- Genentech, Inc.
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at…
- Trial name
- NCT07015983
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 97 sites in United States, Argentina and 14 more
- Volunteers
- 89 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric…
- Trial name
- VOCAL-EXT (NCT05962788)
- Testing
- voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 4 people
- Sponsor
- Aurinia Pharmaceuticals Inc.