Clinical trials: C3G
C3 Glomerulopathy (C3G), Paroxysmal Nocturnal Hemoglobinuria (PNH)
Managed Access Programs for LNP023, Iptacopan
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan
- Trial name
- NCT05222412
- Testing
- Iptacopan
- Sponsor
- Novartis Pharmaceuticals
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
C3 Glomerulopathy, Idiopathic Immune Complex-Mediated Glomerulonephritis
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated…
- Trial name
- NCT06209736
- Testing
- OMS906 study drug
- Where
- 6 sites in Lithuania, New Zealand and 2 more
- Volunteers
- 20 people
- Sponsor
- Omeros Corporation
Oxidative Stress
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers.
- Trial name
- C3G (NCT01230281)
- Testing
- Black bean seed coat extract
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Seoul St. Mary's Hospital
C3G, IC-MPGN
C3G/Primary IC-MPGN EAP
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN.
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis
- Trial name
- NCT04729062
- Testing
- Pegcetacoplan
- Sponsor
- Apellis Pharmaceuticals, Inc.
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.
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
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.
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
C3G, IC-MPGN
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative…
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis
- Trial name
- VALIANT (NCT05067127)
- Testing
- Pegcetacoplan
- Where
- 125 sites in United States, Argentina and 17 more
- Volunteers
- 124 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
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
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
C3 Glomerulopathy (C3G)
Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD
- Trial name
- ACCOLADE (NCT03301467)
- Testing
- Avacopan
- Where
- 45 sites in United States, Belgium and 9 more
- Volunteers
- 57 people
- Sponsor
- Amgen
C3G, IC-MPGN
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.
- Conditions
- C3G, IC-MPGN, Renal Transplant, Complement 3 Glomerulopathy
- Trial name
- NOBLE (NCT04572854)
- Testing
- Pegcetacoplan
- Where
- 25 sites in United States, Argentina and 9 more
- Volunteers
- 13 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
C3 Glomerulonephritis, C3 Glomerulopathy
A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
The primary purpose of this study was to evaluate the efficacy of 12 months of oral ACH-0144471 (also known as danicopan and ALXN2040) in participants with C3G or IC-MPGN based on histologic scoring and proteinuria.
- Conditions
- C3 Glomerulonephritis, C3 Glomerulopathy, Immune Complex Membranoproliferative Glomerulonephritis, IC-MPGN
- Trial name
- NCT03459443
- Testing
- Danicopan
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 22 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
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
Dense Deposit Disease
TP10 Use in Patients With C3 Glomerulopathy (C3G)
The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients with C3G, as measured by the proportion of…
- Trial name
- NCT02302755
- Testing
- TP10
- Where
- United States
- Sponsor
- University of Iowa
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
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.