The following are a list of the Investigator driven and Sponsored clinical trials the Western Health Renal Research Unit has contributed to:
AKTN HDx EXERCISE: A haemodialysis exercise program: a pilot study exploring a new workforce model Sponsor: Deakin University and Western Health
AKTN FAVOURED: A randomised, double-blind,placebo-controlled, factorial-design trial to assess the effect of aspirin and fish oil (omega-3 fatty acids) in the prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney diseaserequiring haemodialysis Sponsor: University of Queensland Australia
AKTN FIX: The CKD-FIX Study: an investigator-initiated, multicentre, prospective, randomised, double-blind, placebo-controlled; parallel-arm trial testing the hypothesis that compared to placebo, uric acid-lowering therapy with xanthine oxidase will significantly slow the progression of kidney failure in patients with moderate to severe chronic kidney disease Sponsor: University of Queensland Australia
AKTN HONEYPOT: A randomized, controlled trial of exit site application of MEDIHONEY™ Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients. The HONEYPOT Study Sponsor: University of Queensland, Australia
AKTN IMPROVE: A randomised, double-blind, placebo-controlled trial to assess the effect of phosphate reduction with lanthanum carbonate on arterial compliance and vascular calcification in patients with chronic kidney disease stages 3-4 Sponsor: University of Queensland Australia
AKTN PDOPPS: Peritoneal Dialysis Outcomes & Practice Patterns - PDOPPs Study Sponsor: University of Queensland Australia
AKTN REMOVE-HD: A single arm, non‐randomised device trial to assess the effect of the Theranova Dialyser of albumin and uraemic solutes in patients with Stage V chronic kidney disease requiring haemodialysis Sponsor: University of Queensland Australia
ASCEND D: A phase 3 randomized, open-label (sponsor-blind), active controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents Sponsor: GlaxSmithKline Research and Development Ltd UK
ASCEND ND: A phase 3 randomized, open-label (sponsor-blind), activecontrolled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa Sponsor: GlaxoSmithKline Research and Development Ltd UK
ASCEND ID: A 52-week open-label (sponsor-blind), randomized, active-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of daprodustat compared to recombinant human erythropoietin in subjects with anemia associated with chronic kidney disease who are initiating dialysis Sponsor: GlaxoSmithKline Research and Development Ltd UK
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.
CARA PRURITIS: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients with Moderate-to-Severe Pruritus, with a 52-Week Open-label Extension Sponsor: Cara Therapeutics Inc
CHEMOCENTRYX: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Sponsor: ChemoCentryx, Inc.
CL2-78989-011: Dose-response study of gevokizumab (S 78989) 3mg, 10mg, 30mg or 60mg in patients with type 2 diabetes and diabetic kidney disease (DKD). A 66-week, international, multicenter, randomized, double-blind, parallel-group, placebo-controlled study Sponsor: Servier Canada Inc
CONTROLLED EVALUATION OF ANGIOTENSIN RECEPTOR BLOCKERS FOR COVID-19 RESPIRATORY DISEASE: A pragmatic prospective, open-label randomised controlled trial aiming to examine the effectiveness of ARB's on improving the outcomes of people who tested positive for COVID-19 diease. Sponsor: The George Institute Australia
CREDENCE: A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy Sponsor: Janssen-Cilag Pty Ltd
DMX FSGS: A Phase 2a, Double blind, Randomised, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan Sponsor: Dimerix Bioscience Pty Ltd
DMX DKD: A Phase 2, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Diabetic Kidney Disease (DKD) who are Receiving Irbesartan Sponsor: Dimerix Bioscience Pty Ltd
DURECT: A Study to Evaluate the Pharmacokinetics (PK) and Safety of DUR-928 in Subjects with Impaired Kidney Function and Matched Control Subjects with Normal Kidney Function Sponsor: DURECT Corporation USA
EMAN-ANAEMIA PILOT: An Open Labelled Randomized Control trial of the synchronized Electronic MANagement of Anaemia in Chronic Kidney Disease (CKD) compared to Usual Care Anaemia Management Sponsor: Western Health Australia
EMAP-CKD VIC: Electronic Mapping and Assistance to Primary Care in CKD Detection and Management in Victoria – A Pilot project Sponsor: Renal Health Clinic Network and Aboriginal Health Network, Department of Health Victoria
FIGARO: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to standard of care Sponsor: Bayer Australia Ltd
FIDELIO: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease Sponsor: Bayer Australia Ltd
FSGS PODOCYTE: Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic Focal Segmental Glomerulosclerosis: A 2-Part Prospective Study of H.P. Acthar® Gel (PODOCYTE) Sponsor: Novotech Australia Pty Ltd
HUG: Home Dialysis Utilising Tele-Health Guidance and Monitoring Sponsor: Victorian Government
IgA Kira: An Open-label, Phase 2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 in Subjects with IgA Nephropathy (IgAN) and Complement 3 Glomerulopathy (C3G) Sponsor: George Clinical Pty Ltd
JUNIPER: A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Safety and Efficacy Of ANG-3070 in Patients with Primary Glomerular Disease and Persistent Proteinuria Sponsor: Angion Pty Ltd
MANUEVER: A Phase 2A, double blind, randomised, placebo-controlled study in VEGF blockade with CSL346 in patietns with Diabetic Kidney Disease. Sponsor: CSL Behring USA.
MK- 2060-007: A randomized parallel-group, placebo-controlled, double-blind, event-driven, multi-center phase 2 clinical outcome trial of prevention of Arteriovenous Graft Thrombosis and safety of MK-2060 in patients with end stage renal disease receiving hemodialysis Sponsor: Merck Sharp and Dohme (MSD)
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
NEPHROGENEX PYR 311: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Study to Evaluate the Safety and Efficacy of Pyridorin™ (pyridoxamine dihydrochloride) in Subjects with Nephropathy Due to Type 2 Diabetes Sponsor: Medpace Australia Pty Ltd
PSA-EPO: A Phase 2, Open Label, Multicentre, Sequential Dose Finding Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Multiple Doses of Polysialylated Erythropoietin (PSA-EPO) Administered Subcutaneously in Chronic Kidney Disease Subjects Not on Dialysis and Not Receiving Erythropoiesis Stimulating Agents / PSA-EPO-06 Sponsor: Novotech Australia Pty Ltd
ROKD REGISTRY: Registry of Kidney Diseases (RoKD) Sponsor: Department of Health Victoria
RRF: Residual Renal Function in Home Haemodialysis Sponsor: Baxter International
XOMA: Dose-Response Study of Gevokizumab (S 78989) 3mg, 10mg, 30mg or 60mg in Patients with Type 2 Diabetes and Diabetic Kidney Disease (DKD) A 66-Week, International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Sponsor: Servier Laboratories Australia Pty Ltd
