Current Project

ACHIEVE: Aldosterone bloCkade for Helath Improvement EValuation in End-stage Renal Disease. Sponsor: Population Health Research Institute Canada
 

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
 

AFFINITY: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases. Sponsor: Chinook USA
 

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
 

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
 

ASSIST: A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodium-glucoseCotransporter-2 Inhibitors (SGLT2i) Sponsor: Worldwide Clinical Trials Pty Limited
 

BEAT Calci: Better Evidence And Translation for Calciphylaxis Sponsor: University of Sydney
 

BEYOND: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study) Sponsor: Chinook USA
 

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 
 

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
 

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 
 

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
 

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 Sponsor: F. Hoffmann-La Roche Ltd 
 

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
 

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) Sponsor: Vera Therapeutics, Inc South San Francisco 
 

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: Kezar Life Sciences, Inc. 
 

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 
 

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
 

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  
 

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) Sponsor: Alpine Immune Sciences Australia Pty Ltd 
 

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
 

TRACK: Randomised, double-blind, placebo-controlled trial in the treatment of CVD with low dose Rivaroxaban in Advanced CKD. Sponsor: The George Institute Australia
 

VC2: Victorian COVID-19 Vaccines Collection Sponsor:The University of Melbourne
 

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.
 

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 Sponsor: AstraZeneca Pty Ltd
 

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
 

We also lead project interventions for chronic disease detection and management in the primary care setting including novel technology solutions. These include:
 

Chronic Disease IMPACT:  Chronic Disease IMPACT (Chronic Disease early detection and Improved Management in PrimAry Care ProjecT), in collaboration with University of Melbourne and Victoria University
 

Future Health Today in collaboration with the University of Melbourne

For more information regarding the Western Health Renal Research Unit including if you would like to find out about collaborating or participating in any of our trials please contact:

A/Prof Craig Nelson, Head of Renal Services 
Sunshine Hospital
176 Furlong Rd
St Albans 3021
Telephone 61 8345 1333
Email: Craig.Nelson@wh.org.au
 

Prof Eugenia Pedagogos, Head of Renal Clinical Trials
Sunshine Hospital
176 Furlong Rd
St Albans 3021
Telephone +61 8345 1333
Email: eugenia.pedagogos@wh.org.au
 

Shannon Kokoszka, Renal Research Unit Team Leader
Sunshine Hospital
176 Furlong Rd
St Albans 3021
Telephone +61 8395 8058
Email: shannon.kokoszka@wh.org.au