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 commercially sponsored clinical trials:
ALIGN: A Phase III, double-blind, placebo-controlled study to compare efficacy and safety of Atrasentan to placebo in patients with IgA nephropathy. Sponsor: Chinook USA Principal Investigator: Prof Eugenia Pedagogos
AFFINITY: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases. Sponsor: Chinook USA Principal Investigator: Prof Eugenia Pedagogos
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). Sponsor: Dimerix Bioscience Pty Ltd Principal Investigator: Dr Adam Flavell
AT-1501: A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy Sponsor:: Eledon Pharmaceuticals, Inc. Principal Investigator: Dr Adam Flavell
PHOENYCS: A Phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Dapirolizumab Pegol in patients with moderate to severe Systemic Lupus Erythematosis. Sponsor: UCB Biopharma SRL Belgium. Principal Investigator: Dr Andrew Talbot
MANUEVER: A Phase 2A, double blind, randomised, placebo-controlled study in VEGF blockade with CSL346 in patients with Diabetic Kidney Disease. Sponsor: CSL Behring USA. Principal Investigator: Prof Eugenia Pedagogos
ARTEMIS-IGAN: A randomised, double-blind, placebo-controlled, phase III study of the safety and efficacy of OMS721 in patients with IgA Nephropathy. Sponsor: Omeros Corporation USA Principal Investigator: Prof Eugenia Pedagogos
NEFLGARD: A randomised, double-blind, placebo controlled study to evaluate efficacy and safety of nefecon in patients with IgA Nephropathy at risk of progressing to end-stage renal disease. Sponsor: Calliditas Therapeutics AB Sweden Principal Investigator: A/Prof Vicki Levidiotis
Nef-301 OLE: An Open-Label Extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgA Nephropathy who have completed study Nef-301 Sponsor: Calliditas Therapeutics AB Sweden Principal Investigator: A/Prof Vicki Levidiotis
SER150: A Phase 2/3, double-blind, randomised, placebo controlled, parallel groups study evaluating the safety and efficacy of SER150 in patients with well controlled type 2 diabetic patients with Diabetic Kidney Disease and macroalbuminuria. Sponsor: Serodus (AUS) Pty Ltd Principal Investigator: Dr Leny Hidayati
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 Sponsor: Bayer Healthcare Pharmaceuticals Inc., USA Principal Investigator: Prof Eugenia Pedagogos
ORIGIN: A Phase IIB randomized, double-blinded, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of Atacicept in subjects with IgA Nephropathy Sponsor: Vera Therapeutics, Inc South San Francisco Principal Investigator: Prof Eugenia Pedagogos
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 Sponsor:: Otsuka Pharmaceutical Development & Commercialization, Inc. Principal Investigator: Prof Eugenia Pedagogos
Page last updated November 2022
