Clinical trials: Nephritis
IgA Nephropathy
Phase 2b Open-Label Repeat Kidney Biopsy Study
Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline
- Trial name
- NCT06740526
- Testing
- Sibeprenlimab
- Where
- 19 sites in United States, Argentina and 3 more
- Volunteers
- 56 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Lupus Nephritis
Aurinia Renal Response in Active Lupus With Voclosporin
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
- Trial name
- AURORA (NCT03021499)
- Testing
- Voclosporin
- Where
- 185 sites in United States, Argentina and 29 more
- Volunteers
- 358 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
IgA Nephropathy
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin…
- Trial name
- NCT05775042
- Testing
- CM338
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Keymed Biosciences Co.Ltd
Lupus, Systemic Lupus Erythematosus
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).
- Conditions
- Lupus, Systemic Lupus Erythematosus, Lupus Nephritis
- Trial name
- SOLUNA (NCT07598396)
- Testing
- Mosunetuzumab
- Where
- 24 sites in Argentina, Brazil and 4 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy
Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)
The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.
- Conditions
- Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, Membranous Nephropathy
- Trial name
- RENEW (NCT05162066)
- Testing
- BCX9930
- Where
- 11 sites in France, Italy and 2 more
- Volunteers
- 2 people
- Sponsor
- BioCryst Pharmaceuticals
Glomerulonephritis
Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency
The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function.
- Trial name
- NCT05505955
- Testing
- HRS-5965
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Lupus Nephritis (LN)
Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
- Trial name
- NCT07363460
- Testing
- HSK39297 200mgQD, HSK39297 300mgQD
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Lupus Nephritis
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest.
- Trial name
- OBSErve-LN (NCT06527872)
- Testing
- None (Observational study)
- Where
- 7 sites in United States, France and 2 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
IgA Nephropathy
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.
- Trial name
- NCT02052219
- Testing
- Blisibimod
- Sponsor
- Anthera Pharmaceuticals
Focal Segmental Glomerulosclerosis (FSGS)
A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147
The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.
- Trial name
- NCT05955872
- Testing
- VX-147
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G)
Chinese Adults With Kidney Disease
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases.
- Conditions
- Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), IC-MPGN
- Trial name
- NCT07522099
- Testing
- ADX-038, Telitacicept
- Where
- 9 sites in China
- Volunteers
- 30 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Lupus Nephritis
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response [CRR] or…
- Trial name
- SIRIUS-LN ext (NCT06711887)
- Testing
- Ianalumab
- Where
- 51 sites in United States, Brazil and 16 more
- Volunteers
- 348 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
To demonstrate the efficacy of SHR-1314 at Week 12 in subjects with proliferation lupus nephritis in terms of improvement of 24h UPCR, compared to placebo.
- Trial name
- NCT04924296
- Testing
- SHR-1314
- Volunteers
- 60 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA.
- Trial name
- SELECT-SLE (NCT07523542)
- Testing
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg)., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Biotech
Glomerulonephritis, IGA, Immunoglobulin A Nephropathy
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months.
- Trial name
- NCT06797518
- Testing
- Iptacopan
- Where
- 19 sites in United States, Argentina and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
The purpose of this study is to evaluate the effectiveness and safety of Pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting.
- Trial name
- NCT07746895
- Testing
- Pegcetacoplan
- Where
- 101 sites in Australia, Austria and 12 more
- Volunteers
- 150 people
- Sponsor
- Swedish Orphan Biovitrum
Kidney Diseases, Kidney Diseases, Chronic
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN).
- Conditions
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis
- Trial name
- NCT06858319
- Testing
- zigakibart
- Where
- 26 sites in United States, Argentina and 7 more
- Volunteers
- 220 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis.
- Trial name
- NCT02081183
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Maintenance Phase, Cyclophosphamide, Induction Phase
- Where
- 2 sites in Venezuela
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
C3 Glomerulopathy, C3 Glomerulonephritis
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants with C3G who also had significant…
- Conditions
- C3 Glomerulopathy, C3 Glomerulonephritis, Dense Deposit Disease
- Trial name
- NCT03369236
- Testing
- Danicopan
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.