Clinical trials: IgAN - IgA Nephropathy
IgA Nephropathy
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject
The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.
- Trial name
- NCT05398510
- Testing
- SHR-2010 injection
- Where
- China
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
IgA Nephropathy
A Phase IIa Study in Primary IgA Nephropathy Patients
This is a phase IIa, multicenter, single-arm, open-label study to evaluate the safety and efficacy of XH-S003 in patients with primary IgA nephropathy
- Trial name
- NCT07634744
- Testing
- XH-S003 Capsule
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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
IgA Nephropathy, Lupus Nephritis
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
- Conditions
- IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, C3 Glomerulonephritis
- Trial name
- NCT03453619
- Testing
- APL-2
- Where
- 17 sites in United States
- Volunteers
- 21 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria，IgA Nephropathy
Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects
The study is designed as a single-center, randomized, open-label, cross-over phase I clinical trial with the intention of recruiting 16 healthy subjects.
- Trial name
- NCT06490991
- Testing
- HRS-5965 tablets；HRS-5965 capsules
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy…
- Trial name
- NCT06004947
- Testing
- CCX168, Midazolam, Celecoxib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
IgA Nephropathy (IgAN)
IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy
Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study
- Trial name
- NCT07886476
- Testing
- IBI3034, Telitacicept
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy
Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries (United States [US], United…
- Trial name
- HONUS (NCT05200871)
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 487 people
- Sponsor
- Travere Therapeutics, Inc.
IgAN, C3G
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
- Conditions
- IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN)
- Trial name
- NCT06989359
- Testing
- ADX-038 Dose Level 2, ADX-038 Dose Level 1
- Where
- 38 sites in United States, Australia and 6 more
- Volunteers
- 45 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Glomerulonephritis
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort.
- Trial name
- NCT05517980
- Testing
- KP104
- Volunteers
- 52 people
- Sponsor
- Kira Pharmacenticals (US), LLC.
IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria
A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
- Trial name
- NCT07035665
- Testing
- HRS-5965 Capsules
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
IgA Nephropathy
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.
- Trial name
- NCT01224028
- Testing
- Tacrolimus
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Astellas Pharma Inc
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
Berger Disease, Bergers Disease
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to <18 years with primary immunoglobulin A nephropathy (IgAN).
- Conditions
- Berger Disease, Bergers Disease, IgA Nephropathy, Immunoglobulin A Nephropathy
- Trial name
- ADVANCE (NCT07498335)
- Testing
- Drug: Atrasentan
- Where
- 18 sites in United States, China and 5 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
IgA Nephropathy
A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants
The goal of this clinical trial is to evaluate the effect of food (a high-fat, high-calorie meal) on the PK of a single oral dose of budesonide delayed release tablet in healthy participants.
- Trial name
- NCT07897240
- Testing
- Budesonide delayed release tablet
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Triastek, lnc.
Immunoglobulin A Nephropathy (IgAN)
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time.
- Trial name
- PREVAIL (NCT06935357)
- Testing
- Felzartamab
- Where
- 265 sites in United States, Argentina and 26 more
- Volunteers
- 454 people
- Sponsor
- Biogen
IgA Nephropathy
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d.
- Trial name
- APPLAUSE-IgAN (NCT04578834)
- Testing
- LNP023
- Where
- 177 sites in United States, Argentina and 33 more
- Volunteers
- 518 people
- Sponsor
- Novartis Pharmaceuticals
IGA Nephropathy
A Study of Treatment Patterns and Real-World Outcomes in IgA Nephropathy Patients in the United States
The aim of this study was to characterize real-world treatment patterns, including therapy sequences, escalation, and duration, and treatment outcomes in IgA nephropathy (IgAN) patients in the United States (US).
- Trial name
- NCT07757048
- Where
- United States
- Volunteers
- 6,286 people
- Sponsor
- Novartis Pharmaceuticals
Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
- Conditions
- Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy, IgA Nephropathy
- Trial name
- NCT03719443
- Testing
- VIS649
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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