Clinical trials: Glomerular Diseases
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
Glomerular Filtration Rate, Heart Failure
MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure
The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance…
- Trial name
- NCT07349797
- Testing
- Lumitrace, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR), Iohexol
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- MediBeacon
Minimal Change Disease (MCD), IgA Nephropathy (IgAN)
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN.
- Conditions
- Minimal Change Disease (MCD), IgA Nephropathy (IgAN), Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- NCT07614477
- Testing
- EVER001
- Where
- 2 sites in China
- Volunteers
- 45 people
- Sponsor
- Everest Medicines (China) Co.,Ltd.
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.
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.
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.
Complement Mediated Primary or Secondary Glomerular Diseases
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06674915
- Testing
- HRS-5965 capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Lupus Nephritis
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
The purpose of this study was to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).
- Trial name
- NCT05781750
- Testing
- zetomipzomib
- Where
- 50 sites in United States, Argentina and 10 more
- Volunteers
- 84 people
- Sponsor
- Kezar Life Sciences, Inc.
Chronic Kidney Disease, Renal Insufficiency
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.
- Trial name
- NCT00908310
- Testing
- Omniscan
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- GE Healthcare
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.
Lupus Nephritis
Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis
The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy…
- Trial name
- NCT05232864
- Testing
- Secukinumab
- Where
- 18 sites in Australia, Brazil and 11 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
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
Proteinuria
Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria
The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.
- Trial name
- NCT05314231
- Testing
- ALXN1720
- Where
- 2 sites in South Korea
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Kidney Disease, Type 2 Diabetes
A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to…
- Trial name
- NCT01500798
- Testing
- 20 mg bardoxolone methyl
- Volunteers
- 18 people
- Sponsor
- Biogen
Lupus Nephritis, Immunoglobulin A Nephropathy
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis …
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, Membranous Nephropathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- RUBY-3 (NCT05732402)
- Testing
- Povetacicept
- Where
- 30 sites in United States, Australia and 2 more
- Volunteers
- 72 people
- Sponsor
- Alpine Immune Sciences, Inc.
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
Chronic Kidney Disease, Atherosclerotic Cardiovascular Disease
A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.
The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney…
- Trial name
- NCT06675175
- Testing
- AZD4144
- Where
- 15 sites in United States, Bulgaria and 2 more
- Volunteers
- 29 people
- Sponsor
- AstraZeneca
Lupus Nephritis (LN)
Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.
- Trial name
- COMPASS (NCT05609812)
- Testing
- Atacicept
- Where
- 33 sites in United States, Puerto Rico and 1 more
- Sponsor
- Vera Therapeutics, 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
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.