Renal Clinical Trials

The Royal North Shore Hospital Renal Clinical Trial Unit has a strong research history, participating in Phase 2 to Phase 4 clinical research for more than 20 years. We have a high performing, research-oriented unit, working to deliver best-practice healthcare and overall community wellbeing.

With a strong focus on collaboration, our unit works closely with the community, our workforce and research partners to provide high-quality, evidence-based healthcare.

The Renal Clinical Trial Unit is led by a clinician supported by two full time trial coordinators and a part time research associate. At any given time, our team co-ordinates 15 to 25 investigator-initiated or industry sponsored clinical trials, while also working in a busy clinical environment caring for patients with kidney diseases.

Our research investigates a broad range of conditions including, chronic kidney disease, diabetic kidney disease, cardiovascular health, glomerular disease, dialysis and its related complications, transplantation, hypertension, renal supportive care and pregnancy related outcomes.

The Renal Clinical Trial Unit is currently undertaking a range of investigator-initiated and industry-sponsored trials.


Dr Muh Geot Wong

Professor Carol Pollock

Professor
Medicine, Northern Clinical School
Kolling Institute

Professor Greg Fulcher

Senior Staff Specialist, Endocrinology, Royal North Shore Hospital
Clinical Professor, Medicine, University of Sydney

Associate Professor Sarah Glastras

Senior Staff Specialist, Endocrinology, Royal North Shore Hospital
Associate Professor of Medicine, University of Sydney

Dr Emma O’Lone

Dr Stella McGinn

Dr Yvonne Shen

Dr Sarah Roxburgh

Dr Bruce cooper

Dr Vikram Puttaswamy

Dr Susan Wan

GRIT

Trial Details: Glomerular Disease Registry

Populations: Glomerular Disease

PI: Dr Muh Geot Wong

Sponsor: The George Institute

PHOSPHATE

Trial Details: A Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis

Populations: Kidney Failure, Chronic Hyperphosphatemia

PI Dr Emma O’Lone

Sponsor: The University of Queensland, NHMRC

TRACK

Trial Details: Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

Populations: Chronic Kidney Diseases, End-Stage Kidney Disease, Cardiovascular Disease

PI: Dr Muh Geot Wong

Sponsor: The George Institute

CARSK

Trial Details: Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates Populations

Populations: Cardiovascular Diseases, End Stage Renal Disease, Kidney Transplantation, Dialysis Related Complication

PI: Dr Stella McGinn

Sponsor: University of British Columbia

RESOLVE

Trial Details: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Populations: Chronic Kidney Diseases, End-Stage Kidney Disease, Cardiovascular Disease

PI: Dr Yvonne Shen

Sponsor: The George Institute

REDUCCTION

Trial Details: Reducing the burden of dialysis Catheter Complications in patients with kidney disease: a National approach

Populations: End stage kidney disease, Haemodialysis Catheter complications

PI: Dr MuhGeot Wong

Sponsor: NHMRC

TIMELY

Trial Details: Treatment modalities for the InfirM ElderLY with end stage kidney disease: the TIMELY study

Populations: End Stage Renal Disease

PI: Dr Sarah Roxburgh

Sponsor: The George Institute, NHRMC Program Grant

CLARITY

Trial Details: Controlled evaluation of Angiotensin Receptor Blockers for COVID-19 respiratory disease

Populations: End Stage Renal Disease, Cardiovascular disease

PI: Professor Carol Pollock

Sponsor: The George Institute 

HaBIT 1

Trial Details: Incidence of De novo HLA Antibody formation after Transfusion with blood products in patients with end stage kidney disease who are planned for live donor kidney transplant: A prospective study

Populations: Live Donor transplant patients at participating hospitals who have a red cell transfusion scheduled.

PI: Dr Stella McGinn

Sponsor: Australian Red Cross Blood Service

TESTING

Trial Details: Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) (TESTING)

Populations: IgA Glomerulonephritis

PI: Dr Bruce Cooper

Sponsor: The George Institute

Teach PD

Trial Details: A pragmatic, registry-based, international, cluster-randomised controlled trial examining the use of TEACH-PD training modules for incident PD patients versus existing practices on the rate of PD-related infections

Populations: CKD, Peritoneal dialysis

PI: Dr Bruce Cooper

Sponsor: The University of Queensland acting through Australasian Kidney Trials Network (AKTN)

CONTEND

Trial Details: CONsumer views of Treatment options for Elderly patieNts with kiDney failure

Populations: CKD, End Stage Kidney Disease

PI: Dr Sarah Roxburgh

Sponsor: The George Institute, NHRMC Program Grant

PREVENA

Trial Details: Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant (IMPART)

Populations: Kidney Transplant, Vascular Surgery

PI: Dr Vikram Puttaswamy

Sponsor: Royal North Shore Hospital

ACHIEVE

Trial Details: Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

Populations: ESRF, Dialysis patient

PI: Dr Susan Wan

Sponsor: Hamilton Health Sciences

AlIGNI

Trial Details: A Phase 3, Randomized, Double-blind, Placebocontrolled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)

Populations: IgA Nephropathy

PI: Dr Muh Geot Wong

Sponsor: Chinook Therapeutics

AFFINITY

Trial Details: The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.

Populations: IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease

PI: Dr Muh Geot Wong

Sponsor: Chinook Therapeutics

FLOW

Trial Details: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

Populations: Diabetes Mellitus, Type 2

PI: Dr Muh Geot Wong

Sponsor: Novo Nordisk

DUPLEX

Trial Details: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

Populations: Focal Segmental Glomerulosclerosis

PI: Dr Muh Geot Wong

Sponsor: Retrophin, Inc.

PROTECT

Trial Details: A randomized, multicenter, double-blind, parallel-group, active-control study of the efficacy and safety of sparsentan for the treatment of immunoglobulin A nephropathy

Populations: Immunoglobulin A Nephropathy

PI: Dr Muh Geot Wong

Sponsor: Retrophin, Inc.

IONIS

Trial Details: An Open-Label Phase 2a Clinical Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Subjects With Primary IgA Nephropathy

Populations: Primary IgA Nephropathy

PI: Dr Muh Geot Wong

Sponsor: Ionis Pharmaceuticals, Inc. 

ENVISION VIS649 (Previously called VISTERRA)

Trial Details: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy

Populations: IgA Disease

PI: Dr MuhGeot Wong

Sponsor: Visterra, Inc

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