Clinical trials: C3G, active
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients
- Trial name
- PRESERVE (NCT07898774)
- Testing
- Pegcetacoplan
- Where
- 33 sites in Brazil, Canada and 8 more
- Volunteers
- 30 people
- Sponsor
- Swedish Orphan Biovitrum
C3 Glomerulopathy (C3G), Healthy Adult Participants
A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
This study is the first time the new medicine CPV-104 is being tested in people. CPV-104 is designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy (C3G), an ultra-rare kidney…
- Trial name
- Essential One (NCT07483827)
- Testing
- CPV-104
- Where
- 17 sites in Austria, Belgium and 10 more
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- eleva GmbH
C3G, IC-MPGN
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex…
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis
- Trial name
- VALE (NCT05809531)
- Testing
- Pegcetacoplan
- Where
- 47 sites in United States, Argentina and 13 more
- Volunteers
- 100 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Atypical Hemolytic Uremic Syndrome
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.
- Trial name
- NCT05795140
- Testing
- Iptcaopan 200 mg
- Where
- 9 sites in Brazil, China and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
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
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Kira Pharmacenticals (US), LLC.
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
Infections, Enterobacteriaceae
Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria
The objective of the research is to evaluate the value of testing for ESBL carriage by rectal swab to predict the risk of ESBL-producing Enterobacteriaceae infections in intensive care.
- Trial name
- SCREEN ICU (NCT07345923)
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Strasbourg, France
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.
C3 Glomerulopathy
Study of NM8074 in Adult C3 Glomerulopathy Patients
This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.
- Trial name
- NCT05647811
- Testing
- NM8074
- Volunteers
- 18 people
- Sponsor
- NovelMed Therapeutics
IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)
QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues.
- Conditions
- IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy (C3G), Primary Membranous Nephropathy
- Trial name
- NCT07730632
- Testing
- QLS7305 Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
C3 Glomerulopathy
Home Reported Outcomes in C3G Study
The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-related Quality of Life (HRQoL) experienced by C3 glomerulopathy (C3G) patients and their caregivers.
- Trial name
- NCT07029542
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
C3 Glomerulopathy, Complement-mediated Kidney Disease
CHART-C3G/CLNP023B12011
This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their…
- Conditions
- C3 Glomerulopathy, Complement-mediated Kidney Disease, Proteinuria
- Trial name
- NCT07331259
- Testing
- Iptacopan
- Volunteers
- 83 people
- Sponsor
- Novartis Pharmaceuticals
Complement 3 Glomerulopathy
A Study of Complement 3 Glomerulopathy (C3G) Patients Treated With Iptacopan Through an Early Access Program in Spain
This study aims to characterize the patient profiles and the clinical experience of iptacopan treatment in adult patients with C3G treated through an early access program (EAP) in Spain.
- Trial name
- ROUTE-C3G (NCT07598448)
- Where
- 2 sites in Spain
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Hemolytic-Uremic Syndrome, Membranoproliferative Glomerulonephritis
New Analytic Tools for aHUS and C3G Diagnosis
This protocol is part of a larger project, COMPRare (COMPlement-mediated Rare kidney diseases), which has been financed on behalf of the EJP RD (European Joint Programme on Rare Diseases) program of EU and is leaded by a…
- Conditions
- Hemolytic-Uremic Syndrome, Membranoproliferative Glomerulonephritis, Healthy
- Trial name
- COMPRare (NCT05985122)
- Testing
- C3NEF assay
- Where
- Italy
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Glomerulopathy, C3G
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
This is a prospective, multicenter, non-interventional, observational pharmacological real-world study to characterize longitudinal changes in ex vivo biomarkers of complement activation in patients with C3G and primary IC-MPGN…
- Conditions
- Glomerulopathy, C3G, Membranoproliferative Glomerulonephritis (MPGN)
- Trial name
- COMPASS (NCT07904338)
- Testing
- Blood sample
- Where
- Italy
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
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
C3 Glomerulopathy
Fabhalta Capsules Specified Drug-use Survey
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
- Trial name
- NCT07156149
- Where
- 29 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Paroxysmal Nocturnal Hemoglobinuria, C3 Glomerulopathy
A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
This is a post-marketing surveillance study conducted as part of the Risk Management Plan (RMP) for South Korea, to evaluate the safety and effectiveness of iptacopan in real-world clinical settings for the treatment of either…
- Trial name
- NCT07416162
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
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.
C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
- Trial name
- NCT03955445
- Testing
- LNP023
- Where
- 53 sites in United States, Argentina and 15 more
- Volunteers
- 225 people
- Sponsor
- Novartis Pharmaceuticals