Concord+Renal+Unit+Research

Website: http://www.sswahs.nsw.gov.au/concord/ethics/main.cfm Manager: Ms Virginia Turner 9767 5622 email: virginia.turner@sswahs.nsw.gov.au Admin Assistant: Ms Deb Shearer 9767 6233 email: debra.shearer@sswahs.nsw.gov.au Contact number: **9767 6576** Ms Samantha Hand: samantha.hand@sswahs.nsw.gov.au Ms Sarah Gallagher: sarah.gallagher@sswahs.nsw.gov.au Ms Lilian Mwaijele: lilian.mwaijele@sswahs.nsw.gov.au
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 * Concord Repatriation and General Hospital Research Office:**
 * Concord Renal Unit Research:**
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The Concord Renal Unit has an active program of clinical research. A major theme of the program is involvement in studies designed to improve outcomes for people with kidney disease. Our program includes studies initiated both by the Concord Unit and by collaborators from other Australian and international units. The Concord Renal unit has strong links with the leading edge of research in kidney disease. Two of our staff, A/Prof Martin Gallagher and A/Prof Meg Jardine have appointments at a leading, international research organisation, The George Institute for Global Health, and are both leading international research collaborations. Dr Shaundeep Sen brings expertise in vascular function and uraemic toxin research, having recently completed doctoral studies in the determinants of endothelial health in CKD with the Queen Elizabeth and Royal Adelaide Hospital and University of Adelaide. Dr Celine Foote is leading studies on the impact of managing advanced kidney disease in elderly people.

Examples of clinical trials that are ** currently recruiting ** participants follow.


 * SONAR Study (diabetic nephropathy)
 * FINESSE
 * PEXIVAS
 * IMPROVE-CKD
 * PRESERVE
 * TESTING

Trials that are ongoing or recently completed trials include the ACTIVE Dialysis trial and the FAVOURED trial which will produce evidence to guide the management of people receiving haemodialysis therapy.

 The SONAR study is examining the effect of atrasentan (compared to placebo) upon the progression of kidney disease in patients with diabetic nephropathy. This is an international multi-centre study, supported by Abbvie, The study is currently recruiting patients with diabetes and impaired kidney function who have significant amounts of protein in their urine. The study is aiming to address one of the major gaps in our treatments to prevent the progression of diabetic kidney disease, that of treatments that reduce urine protein loss but also do not reduce blood pressure too much. It will also provide important additional insights into whether such urine protein reduction slows the progression of such kidney disease. Details of the trial can be found at https://clinicaltrials.gov/ct2/show/NCT01858532?term=sonar&rank=1
 * The SONAR Study**

top The ‘FINESSE' Trial: Filtration In the Neuropathy of End Stage kidney disease Symptom Evolution Australian and New Zealand Clinical Trials Registry number: ACTRN1260090006615280 The study will address the pressing need for novel strategies to impact on the pain and disability burden of the neuropathy associated with chronic kidney disease (uraemic neuropathy). With no recognized disease course-altering treatment other than transplantation, there is a pressing need for novel strategies to mitigate this disease burden. FINESSE will randomize 230 people undergoing maintenance dialysis to HDF or standard dialysis for up to 4 years to determine whether HDF reduces the occurrence and slows the progression of uraemic neuropathy in patients requiring regular maintenance haemodialysis. This trial has been initiated by staff of the Renal Units of Concord and Royal Prince Alfred Hospitals. It is being run by a collaboration of dialysis, neuropathy and trial experts in a number of Australian renal units.

__** The PRESERVE Study **__  The Prevention of Serious Adverse Events following Angiography is the definitive study of the effect of two commonly-used treatments to prevent the deterioration of kidney function following intra-arterial use of radiocontrast agents. The study compares n-acetylcysteine (NAC) vs placebo and sodium bicarbonate vs normal saline in a factorial design, with participants having a 25% chance of receiving any of the 4 potential combinations of these treatments. The PRESERVE Study was initiated the Veterans Administration in the US and is currently operating in the US, Australia, Malaysia and New Zealand. In our region the study is coordinated by the George Institute for Global Health and is supported by an NHMRC Project Grant. A design paper (link below) explains the background to the study in more detail.

 top The ‘**ACTIVE Dialysis**’ Trial: **__A__ __C__linical __T__rial of Intensi__VE__ Dialysis** Clinicaltrials.gov trial registration number: Clinicaltrials.gov #: NCT00649298 ACTIVE Dialysis is a prospective, randomised trial designed to provide definitive evidence on the benefits and costs of extending weekly haemodialysis hours beyond current standards. A small proportion of haemodialysis patients dialyse for extended hours in the home setting. These patients are healthier than the average dialysis patient on multiple parameters. They have better clincial outcomes and quality of life although the extent to which this is due to the extended hours or simply to the fact that they are healthier to begin with is unknown. The study will randomise 200 participants to standard (≤18 hours per week) or extended (≥24 hours per week) hours of dialysis for 12 months. Participants are being enrolled from both the home haemodialysis program and from hospital dialysis settings. This trial is endorsed by the Australasian Kidney Trials Network, and is being fully coordinated through the George Institute for Global Health.

 top The ‘**FAVOURED**’ Trial: **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 disease requiring haemodialysis.** Australian and New Zealand Clinical Trials Registry number: ACTRN12607000569404 The objectives of this trial are to determine whether the use of the omega-3 fatty acids and to a lesser extent, aspirin, will effectively improve postsurgical outcomes for patients with de novo arterio-venous fistulae (AVF). The study population are patients with stage IV or V chronic kidney disease (CKD) who require or will require haemodialysis (HD) and who are scheduled to undergo creation of an AVF. The primary outcome is AVF Access Failure, which is a composite of Thrombosis, AVF Abandonment, and Cannulation Failure during the Cannulation Assessment Period (CAP). Secondary outcomes include AVF access failure according to strata of aspirin use, safety and adverse events of omega-3 fatty acids and aspirin alone or in combination, catheter use, and rescue interventions. This trial is being fully coordinated through the Australasian Kidney Trials Network (Trial no. AKTN 06.01).
 * FAVOURED: __F__ish oil and __A__spirin in __V__ascular access __OU__tcomes in __RE__nal __D__isease**

 top The ‘**PEXIVAS**’ Trial: **Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomized controlled trial.** European Union Drug Regulating Authorities Clinical Trials protocol number: 2009-013220-24 Clinicaltrials.gov registration number: NCT00987389 This trial aims to study the combination of Plasma Exchange and either standard-dose or reduced-dose glucocorticoids in the treatment of ANCA-associated vasculitis. Eligible patients with ANCA-associated vasculitis are randomised 1:1 to receive Plasma Exchange/No Plasma Exchange, then within each PLEX group, randomised 1:1 to receive standard dose / reduced dose glucocorticoids. Participants will also receive standard immunosuppressive therapy. The follow-up period for all patients will be between 5 and 7 years duration. The primary outcome measure will be time to the composite endpoint of all-cause mortality or end-stage renal disease. This trial is a large, multi-centre, international randomised controlled trial coordinated centrally out of the Birmingham Clinical Trials Unit, on behalf of the European Vasculitis Study Group (UK) and the Vasculitis Clinical Research Consortium (USA). The AKTN is facilitating the Australian and New Zealand arm of the trial. This trial is being facilitated through the Australasian Kidney Trials Network.
 * PEXIVAS: __P__**lasma **__EX__**change and glucocorticoids **__I__**n anti-neutrophil cytoplasm antibody associated systemic **__VAS__**culitis: a randomised controlled trial

top The DETECT Study The '**DETECT**' Trial: **DETECTing bowel cancer through screening in CKD** Australian and New Zealand Clinical Trials Registry number: ACTRN12611000538943 This study aims to assess the efficacy, effectiveness and patient perspective to screening for colorectal cancer using an iFOB testing kit in CKD subjects. Malignancy is a major cause of death in those with advanced CKD, receiving dialysis or with a kidney transplant. There is however limited data on the benefits, inidividual or economic, of screening for malignancy in this population. Eligible patients will be aged 35-70 years of age, with CKD stage III-V, including those on dialysis or recipient of a kidney transplant. Exclusion criteria include recent colonoscopy, or known personal or first degree family history of colorectal cancer. If a subject has a positive iFOB test, then they will be offered a colonoscopy, as per standard care in the community. There will be no cost to the participant. A total of over 4000 participants will be recruited from multiple sites both within New South Wales, and overseas. This trial is being coordinated through the Centre for Transplant and Renal Research, Westmead Hospital, NSW.

 The Australasian Kidney Trials Network (AKTN) is coordinating a randomised clinical trial investigating phosphate reduction though Lanthanum use, and its effect on arterial compliance, left ventricular mass and vascular calcification in Chronic Kidney Disease (CKD) patients. This trial is known as the IMPROVE-CKD Trial (IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease). The main objective of the study is to determine whether use of a phosphate binder (lanthanum carbonate) in subjects with chronic kidney disease (CKD) stages 3b and 4 will reduce the risk and burden of cardiovascular disease. Patients with CKD 3b and 4 have a substantially higher incidence of cardiovascular disease contributing to significant morbidity and mortality. Phosphate imbalance is a putative non-traditional risk factor for cardiovascular disease in this population (association studies) and lowering of serum phosphate levels with a phosphate binder may be associated with reduced morbidity and mortality. To date, there has not been an adequately powered, placebo-controlled multi-centre RCT evaluating the effects of phosphate-lowering therapy on the reduction of CVD burden in CKD patients. This trial will examine CV and CKD disease progression through measurement of peripheral arterial stiffness, vascular calcification and left ventricular mass and FGF-23 and bone mineral density.

 IgA nephropathy is a condition that occurs around the world and can lead to progressive loss of kidney function. There is conflicting evidence on whether treatment with corticosteroids will improve outcomes and slow the loss of kidney function. The TESTING study will randomise people with biopsy-proven IgA nephropathy and proteinuria to a 6 month course of corticosteroids or placebo.