Clinical trials: Glomerular Diseases
Immunoglobulin A (IgA) Nephropathy
Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
- Trial name
- IGNAZ (NCT05065970)
- Testing
- Felzartamab
- Where
- 59 sites in United States, Australia and 13 more
- Volunteers
- 54 people
- Sponsor
- HI-Bio, A Biogen Company
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
Obesity
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of…
- Trial name
- NCT02229214
- Testing
- Qsymia
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Fabry Disease
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function.
- Trial name
- BALANCE (NCT02795676)
- Testing
- PRX-102 (pegunigalsidase alfa), agalsidase beta
- Where
- 29 sites in United States, Czechia and 10 more
- Volunteers
- 78 people
- Sponsor
- Protalix
Kidney Diseases, Kidney Injury
Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound.
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Trial name
- NCT05777174
- Testing
- MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 5 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Type 2 Diabetes Mellitus
Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.
- Trial name
- NCT00976495
- Testing
- Dapagliflozin, Hydrochlorothiazide
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 154 people
- Sponsor
- AstraZeneca
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.
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.
Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
- Conditions
- Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy, IgA Nephropathy
- Trial name
- NCT03719443
- Testing
- VIS649
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Kidney Disease
Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with…
- Trial name
- ZENITH-CKD (NCT04724837)
- Testing
- Zibotentan, Dapagliflozin
- Where
- 164 sites in United States, Argentina and 17 more
- Volunteers
- 542 people
- Sponsor
- AstraZeneca
IgA Nephropathy, Immunoglobulin A Nephropathy
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
The ASSIST study was a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs.
- Trial name
- ASSIST (NCT05834738)
- Testing
- Atrasentan
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Glomerulonephritis, Membranous
A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy
This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R) autoantibody positive idiopathic membranous…
- Trial name
- NCT01610492
- Testing
- belimumab
- Where
- 8 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- GlaxoSmithKline
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
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
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
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
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.