Clinical trials: C3 Glomerulopathy
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
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
C3G
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
- Trial name
- APPEAR-C3G (NCT04817618)
- Testing
- iptacopan
- Where
- 87 sites in United States, Argentina and 17 more
- Volunteers
- 98 people
- Sponsor
- Novartis Pharmaceuticals
C3 Glomerulonephritis, Dense Deposit Disease
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
The primary objective of this study was to determine whether ACH-0144471 (also known as danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants with low C3 levels due to either C3G or IC-MPGN.
- Conditions
- C3 Glomerulonephritis, Dense Deposit Disease, C3 Glomerulopathy, Immune Complex Mediated Membranoproliferative Glomerulonephritis
- Trial name
- NCT03124368
- Testing
- Danicopan
- Where
- 3 sites in Australia, Belgium and 1 more
- Volunteers
- 6 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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, 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.
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.
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.
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
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
- Conditions
- C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative, Glomerulonephritis (IC-MPGN), Kidney Transplantation
- Trial name
- PRESERVE (NCT07898774)
- Testing
- Pegcetacoplan
- Where
- 33 sites in Brazil, Canada and 8 more
- Volunteers
- 30 people
- Sponsor
- Swedish Orphan Biovitrum
Complement Mediated Diseases
First-In-Human Clinical Study of the C3 Complement Inhibitor AMY- 101 in Healthy Male Volunteers
Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101.
- Trial name
- NCT03316521
- Testing
- AMY-101
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Amyndas Pharmaceuticals S.A.
Kidney Diseases
Clinical Outcomes of C3 Glomerulopathy and IC-MPGN in Russia: Hybrid Retrospective - Prospective Study
The study is planned to study specificity of the clinical course and treatment outcomes of C3 glomerulopathy (C3G) and Immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged under 18 years and 18 years…
- Trial name
- CRYSTAL (NCT06851845)
- Testing
- No intervention
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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
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
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.
C3 Glomerulopathy, IgA Nephropathy
Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease
The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy [C3G]…
- Trial name
- NCT05083364
- Testing
- ARO-C3
- Where
- 16 sites in Australia, Georgia and 5 more
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
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.
Glomerulonephritis
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence…
- Trial name
- NCT03832114
- Testing
- LNP023
- Where
- 9 sites in United States, France and 4 more
- Volunteers
- 27 people
- Sponsor
- Novartis 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