With a team of experienced research nurses and study coordinators, highly experienced Principal and Associate Investigators and a dedicated Research Fellow, we actively participate in a broad range of early phase national and international clinical trials (commercially sponsored and investigator-lead) as well as leading our own research. The Renal Research Unit has full capability to conduct Phase I-IV interventional trials across a broad range of chronic disease disciplines.
We collaborate with many Australian and International Pharmaceutical companies, Contract Research Organisations and network research groups to trial new and adjunct therapies in Renal, Diabetic and Cardiac disease.
Our partners include the Australian Kidney TrialsNetwork, The George Institute, Baker Heart and Diabetes Research Group to contribute to trialling new therapies and adjunct therapies.
Current active clinical trials:
ACTION3: A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB). Commercial Sponsor: Dimerix Bioscience Pty Ltd Principal Investigator: Dr Adam Flavell
AFFINITY: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases. Commercial Sponsor: Chinook USA Principal Investigator: Prof Eugenia Pedagogos
ALEXION I CAN: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) Commercial Sponsor: Alexion Pharmaceuticals Australasia Pty Ltd Principal Investigator: Prof Eugenia Pedagogos
ALIGN: A Phase III, double-blind, placebo-controlled study to compare efficacy and safety of Atrasentan to placebo in patients with IgA nephropathy. Commercial Sponsor: Chinook USA Principal Investigator: Prof Eugenia Pedagogos
APPLAUSE-IgAN: A multi-center, randomized, double-blind, placebocontrolled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients Commercial Sponsor: Novartis Pharmaceuticals Australia Pty Limited Principal Investigator: Prof Eugenia Pedagogos
ASSIST: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodium-glucoseCotransporter-2 Inhibitors (SGLT2i) Commercial Sponsor: Worldwide Clinical Trials Pty Limited Principal Investigator: Prof Eugenia Pedagogos
BEAT Calci: Better Evidence And Translation for Calciphylaxis Investigator Initiated Sponsor: University of Sydney Principal Investigator: Prof Eugenia Pedagogos
BEYOND: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study) Commercial Sponsor: Chinook USA Principal Investigator: Prof Eugenia Pedagogos
EASi-KIDNEY: Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: A multicenter, international, randomized, double-blind, placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease Commercial Sponsor: Boehringer Ingelheim Pty Ltd Principal Investigator: Prof Eugenia Pedagogos
FIND CKD: A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease Commercial Sponsor: Bayer Healthcare Pharmaceuticals Inc., USA Principal Investigator: Prof Eugenia Pedagogos
IMAGINATION: A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients with Primary IgA Nephropathy at High Risk of Progression Commercial Sponsor: F. Hoffmann-La Roche Ltd Principal Investigator: Prof Eugenia Pedagogos
LUPUS Hi Bio : An Open Label Phase 1b Study of Felzartamab in Lupus Nephritis Commercial Sponsor: Human Immunology Biosciences, Inc. (HI-Bio) Principal Investigator: Dr Andrew Talbot
NN9541-7841: Efficacy, safety and pharmacokinetics of NNC0519-0130 once weekly s.c. versus semaglutide 1.0 mg and placebo in people with chronic kidney disease, with or without type 2 diabetes, and with overweight or obesity: a proof-of-concept and dose-finding study Commercial Sponsor: Novo Nordisk Principal Investigator: Prof Eugenia Pedagogos
ORIGIN3: A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) Commercial Sponsor: Vera Therapeutics, Inc South San Francisco Principal Investigator: Prof Eugenia Pedagogos
PIONEER: A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases Commercial Sponsor: Vera Therapeutics, Brisbane, United States of America Principal Investigator: Prof Eugenia Pedagogos
POSIBIL6ESKD: A Phase 2b / 3, Multicenter, Randomized, Double-blind, Placebo controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis Commercial Sponsor: CSL Innovation Pty Ltd Principal Investigator: Prof Eugenia Pedagogos
PYC-003-CL-001: A Phase 1 Study to Evaluate the Safety,Tolerability, and Pharmacokinetics of Intravenously Administered PYC-003, a Peptide-Phosphorodiamidate Morpholino Oligonucleotide Conjugate, in Healthy Adult Participants and Adult Participants with Confirmed PKD1 Mutation-Associated Autosomal Dominant Polycystic Kidney Disease Commercial Sponsor: PYC Therapeutics WA Principal Investigator: Prof Eugenia Pedagogos
RENAL LIFECYCLE: A Randomized Controlled Clinical Trial to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Severe Chronic Kidney Disease Investigator Initiated Sponsor: The George Institute Global Health Principal Investigator: Prof Eugenia Pedagogos
RAINIER: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER) Commercial Sponsor: Alpine Immune Sciences Australia Pty Ltd Principal Investigator: Prof Eugenia Pedagogos
RUBY: AIS-D03 – An Open-label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects with Autoantibody-associated Glomerular Diseases (RUBY-3) Commercial Sponsor: Alpine Immune Sciences Australia Pty Ltd Principal Investigator: Prof Eugenia Pedagogos
TRACK: Randomised, double-blind, placebo-controlled trial in the treatment of CVD with low dose Rivaroxaban in Advanced CKD. Investigator Initiated Sponsor: The George Institute Australia Principal Investigator: Dr Adam Flavell
VISIONARY: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy Commercial Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Principal Investigator: Prof Eugenia Pedagogos
VISIONARY OLE: A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects
with Immunoglobulin A Nephropathy Commercial Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Principal Investigator: Prof Eugenia Pedagogos
VT-001-0020: A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN Commercial Sponsor: Vera Therapeutics, Brisbane, United States of America Principal Investigator: Prof Eugenia Pedagogos
WACK201: Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients with Glomerular Kidney Diseases and Proteinuria Commercial Sponsor: Walden Biosciences, Inc. Principal Investigator: Prof Eugenia Pedagogos
ZENITH: A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants with Chronic Kidney Disease and High Proteinuria Commercial Sponsor: AstraZeneca Pty Ltd Principal Investigator: Prof Eugenia Pedagogos
ZEUS: Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation Commercial Sponsor: Novo Nordisk. Principal Investigator: Prof Eugenia Pedagogos
Page last updated November 2025
