Clinical trials: SLE Nephritis
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
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.
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, 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
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
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 Nephritis
A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations
To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
- Trial name
- TRUST (NCT01410747)
- Testing
- Tacrolimus
- Where
- 8 sites in Japan
- Volunteers
- 1,484 people
- Sponsor
- Astellas Pharma Inc
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 (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.
Immunologic Diseases, Autoimmune Diseases
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.
- Conditions
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- NCT00035308
- Testing
- Abetimus sodium (LJP 394)
- Where
- 82 sites in United States, Austria and 8 more
- Volunteers
- 330 people
- Sponsor
- La Jolla Pharmaceutical Company
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.
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
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis
This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF…
- Trial name
- LUNAR (NCT00282347)
- Testing
- Rituximab, Mycophenolate mofetil, Methylprednisolone
- Volunteers
- 144 people
- Sponsor
- Genentech, Inc.
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
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.
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
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 Nephritis
Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus Nephritis
This observation study is planned to evaluate the safety and efficacy of the subjects who received CS20AT04 in the phase 1 clinical trial.
- Trial name
- NCT04522505
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Corestemchemon, Inc.
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.