Clinical trials: Glomerular Disease
IgA Nephropathy
Study of BHV-1400 in IgA Nephropathy
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
- Trial name
- NCT07054684
- Testing
- BHV-1400
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 20 people
- Sponsor
- Biohaven Therapeutics Ltd.
Glomerular Disease, Proteinuria
Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.
- Trial name
- NCT04939116
- Testing
- ANG-3070
- Where
- 30 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- Angion Biomedica Corp
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.
Chronic Kidney Disease
Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound.
- Trial name
- NCT05425719
- Testing
- MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 8 sites in United States, China
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- MediBeacon
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
- 3 people
- Sponsor
- Omeros Corporation
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
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, 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
Complement Mediated Primary or Secondary Glomerular Diseases
A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers
Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers.
- Trial name
- NCT06567392
- Testing
- [14C] HRS-5965
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Acute Kidney Injury
Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types
This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different…
- Trial name
- NCT02772276
- Testing
- MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg, MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart
- Where
- 3 sites in United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Anti-Glomerular Basement Membrane Disease
A Clinical Trial With KJ103 in Anti-GBM Disease
An open-label, single-arm Phase II study to evaluate the preliminary efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of KJ103 in patients with anti-GBM disease.
- Trial name
- NCT06607016
- Testing
- KJ103 for Injection, Cyclophosphamide, Glucocorticoids
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
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.
Acute Kidney Injury
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.
- Trial name
- NCT03810833
- Testing
- Brilliance device sensor
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MediBeacon
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.
Lupus Nephritis
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without…
- Trial name
- SELUNE (NCT04181762)
- Testing
- secukinumab
- Where
- 105 sites in United States, Argentina and 32 more
- Volunteers
- 275 people
- Sponsor
- Novartis Pharmaceuticals
pMN, IgAN
Atacicept in Multiple Glomerular Diseases
A study to find how well atacicept works and how safe it is in participants with autoimmune kidney disease.
- Conditions
- pMN, IgAN, Nephrotic Syndrome, MCD
- Trial name
- NCT06983028
- Testing
- Atacicept
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Vera Therapeutics, Inc.
Lupus Nephritis
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.
- Trial name
- NCT05268289
- Testing
- Iptacopan (part 1), Iptacopan (part 2)
- Where
- 74 sites in United States, Argentina and 17 more
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
Immunoglobulin A Nephropathy, Glomerular Disease
Safety and Efficacy Study of VIS649 for IgA Nephropathy
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy, Glomerular Disease, IgAN
- Trial name
- NCT04287985
- Testing
- Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
- Where
- 93 sites in United States, Australia and 13 more
- Volunteers
- 155 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Fabry Disease
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry…
- Trial name
- NCT03566017
- Testing
- pegunigalsidase alfa
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 97 people
- Sponsor
- Chiesi Farmaceutici S.p.A.