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 kidney clinical trials:
ACHIEVE: Aldosterone bloCkade for Helath Improvement EValuation in End-stage Renal Disease. Sponsor: Population Health Research Institute Canada 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
AFFINITY: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases. Sponsor: Chinook USA 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. 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 Sponsor: Novartis Pharmaceuticals Australia Pty Limited 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
BEAT Calci: Better Evidence And Translation for Calciphylaxis Sponsor: University of Sydney Principal Investigator: Prof Eugenia Pedagogos
BI 764198: A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics profile of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis Sponsor: Boehringer Ingelheim Pty Limited 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 Sponsor: Bayer Healthcare Pharmaceuticals Inc., USA Principal Investigator: Prof Eugenia Pedagogos
GOAL: Comprehensive geriatric assessment for frail older people with Chronic Kidney Disease to increase attainment of patient-identified goals – A cluster randomised controlled trial. Sponsor: Australasian Kidney Trials Network Principal Investigator: Dr Leny Hidayati
GLOBAL KIDNEY PATIENT TRIALS NETWORK: A prospective observational cohort study of incident and prevalent patients diagnosed with a kidney disease. Sponsor: The George Institute Australia Principal Investigator: Dr Adam Flavell
KICK 2: A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12- Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects with Moderate-to-Severe Pruritus and Not on Dialysis with an Up to 52-Week Long Term Extension Sponsor: ICON Clinical Research Pty Limited Principal Investigator: Prof Eugenia Pedagogos
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: 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
PALIZIDE: A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis Sponsor: PPD Australia Pty Ltd. Principal Investigator: Dr Andrew Talbot
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
POSIBIL6ESKD: A Phase 2b / 3, Multicenter, Randomized, Double-blind,Placebocontrolled,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 Sponsor: CSL Innovation Pty Ltd 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 Sponsor: The George Institute Global Health Principal Investigator: Prof Eugenia Pedagogos
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
TRACK: Randomised, double-blind, placebo-controlled trial in the treatment of CVD with low dose Rivaroxaban in Advanced CKD. Sponsor: The George Institute Australia Principal Investigator: Dr Adam Flavell
VC2: Victorian COVID-19 Vaccines Collection Sponsor: The University of Melbourne 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
ZEUS: Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation Sponsor: Novo Nordisk. Principal Investigator: Prof Eugenia Pedagogos
Page last updated December 2023
