Recruiting Trials
These trials have completed all initiation requirements and are now actively recruiting participants. The trials listed below include trials that are coordinated, facilitated and endorsed by the AKTN.
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.
FAVOURED: Fish oil and Aspirin in Vascular access OUtcomes in REnal Disease
Australian and New Zealand Clinical Trials Registry number: ACTRN12607000569404
Principal Investigator: Dr Ashley Irish, Department of Nephrology, Royal Perth Hospital, Perth WA
Clinical Research Associates: Ms Peta-Anne Paul-Brent and Dr Mike Watson, AKTN, University of Queensland
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). Contact
or phone +61 7 3176 5817 for more information.
The ‘HONEYPOT’ Trial: A randomised, controlled trial of exit site application of MedihoneyTM Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients.
HONEYPOT: HOney versus Nasal Eradication of staphYlococci for the Prevention Of Tenckhoff infections in PD
Australian and New Zealand Clinical Trials Registry number: ACTRN12607000537459
Principal Investigator: Prof David Johnson, Department of Nephrology, Princess Alexandra Hospital, Brisbane Qld
Clinical Research Associate : Dr Liza Vergara, AKTN, University of Queensland
The main objective of the study is to determine whether daily exit site application of standardised antibacterial honey (MedihoneyTM Antibacterial Wound Gel), in addition to daily cleansing as per standard practice, effectively prevents exit site infections, tunnel infections and peritonitis in peritoneal dialysis (PD) patients compared with standard topical mupirocin prophylaxis of nasal staphylococcal carriers. The study population includes incident and prevalent peritoneal dialysis patients who are able to give informed consent. 370 subjects will be randomised 1:1 to receive either daily, topical exit site application of MedihoneyTM Antibacterial Wound Gel or standard care. The primary outcome measures will be time to first episode of exit site infection, tunnel infection or peritonitis and time to first episode of peritonitis. Secondary outcome measures include a series of event-based objectives and an assessment of costs.
This trial is being fully coordinated through the Australasian Kidney Trials Network (Trial no. AKTN 06.02). Contact for more information, or call + 61 (0)7 3176 5394.
The ‘HERO’ Trial: A randomised, placebo-controlled trial of oxpentifylline on erythropoietin resistance in patients with erythropoietin-resistant anaemia.
HERO: Handling Erythropoietin Resistance with Oxpentifylline
Australian and New Zealand Clinical Trials Registry number: ACTRN12608000199314
Principal Investigator: Prof David Johnson, Department of Nephrology, Princess Alexandra Hospital, Brisbane Qld
Clinical Research Associate: Ms Kate Harlen, AKTN, University of Queensland
The main hypothesis of the study is that oxpentifylline (Trental®) administration will effectively treat erythropoietin- or darbepoietin-resistant anaemia in chronic kidney disease patients. The study population are adult patients with stage 4 or 5 chronic kidney disease including dialysis patients, with significant anaemia that is unresponsive to large doses of either erythropoietin or darbepoietin, and for which there is no clear identifiable cause. 110 patients will be randomised 1:1 to receive either placebo or 400mg oxpentifylline tablets daily for a period of 4 months. The primary outcome measure will be the difference in Erythropoietin Resistance Index (ERI: ratio of erythropoietic stimulatory agent (ESA) dosage and haemoglobin concentration, per kg weight) between the 2 groups at the end of the 4 month study period, adjusted for baseline values. Secondary outcome measures will include Haemoglobin levels, ESA dosage, and blood transfusion requirement.
This trial is being fully coordinated through the Australasian Kidney Trials Network (Trial no. AKTN 06.03). Contact for more information, or call +61 (0)7 3176 1883.
The ‘ACTIVE Dialysis’ Trial: A Clinical Trial of IntensiVE Dialysis
Clinicaltrials.gov trial registration number: Clinicaltrials.gov #: NCT00649298
Principal Investigator: Professor Vlado Perkovic, The George Institute for Global Health, Sydney NSW
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. Led by a steering committee of nephrologists and endorsed by the AKTN, the study is coordinated by the Renal Division at The George Institute for Global Health. The trial is funded by a National Health and Medical Research Council (NHMRC) Project Grant with a supplementary unrestricted grant from Baxter. Participants are being enrolled from both the home haemodialysis and in-centre settings and are randomized to standard or extended weekly hours of haemodialysis for 12 months.
This trial is endorsed by the Australasian Kidney Trials Network, and is being fully coordinated through the George Institute for Global Health. Contact or for further information.
The ‘PEXIVAS’ Trial: Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomized controlled trial.
PEXIVAS: Plasma EXchange and glucocorticoids In anti-neutrophil cytoplasm antibody associated systemic VASculitis: a randomised controlled trial
European Union Drug Regulating Authorities Clinical Trials protocol number: 2009-013220-24
Clinicaltrials.gov registration number: NCT00987389
Principal Investigator (Aus/NZ): Dr Chen Au Peh, Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, SA.
Clinical Research Associate: Ms Kate Harlen, AKTN, University of Queensland
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. Contact for more information, or call +61 (0)7 3176 1883.
The ‘BLOCADE’ Trial: A randomised controlled trial of the beta-blocker carvedilol versus placebo to reduce cardiovascular morbidity and mortality in high-risk patients receiving dialysis: A Feasibility Trial
BLOCADE: Beta-blocker to LOwer CArdiovascular Dialysis Events
Australian and New Zealand Clinical Trials Registry number: ACTRN12609000174280
Principal Investigator: Dr Matthew Roberts, Department of Nephrology, Austin Health, Melbourne Vic
Clinical Research Associate : Dr Liza Vergara, AKTN, University of Queensland
The BLOCADE Feasibility Study aims to inform the final design of a randomised controlled trial with clinically important endpoints to determine whether therapy with the beta-blocker carvedilol will reduce the cardiovascular morbidity and mortality of patients receiving dialysis. The major aim of the Feasibility Study is thus to determine the tolerability of carvedilol in this population.
Participants will be patients over the age of 50 years, or those over 18 years with either diabetes or cardiovascular disease. After a run-in phase, patients will be randomised to carvedilol, titrated to the maximum tolerated dose of 25mg twice daily, or placebo titrated in an identical fashion. Patients will be followed for 12 months to determine tolerability in terms of the proportion of participants not tolerating carvedilol in the Run-in Phase and post Randomisation, as well as the incidence of major adverse effects. The Feasibility Study will recruit 150 participants and follow them for 12 months.
This trial is being fully coordinated through the Australasian Kidney Trials Network (Trial no. AKTN 08.01). Contact for more information, or call + 61 (0)7 3176 5394.
The ‘IMPROVE’ Trial: 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
IMPROVE: IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease
Australian and New Zealand Clinical Trials Registry number: ACTRN12610000650099
Principal Investigators:
- Assoc Professor Nigel Toussaint, Department of Nephrology, Royal Melbourne Hospital, Melbourne Vic and
- Assoc Professor Eugenie Pedagogos, Department of Nephrology, Royal Melbourne Hospital, Melbourne Vic
Clinical Project Manager: Donna Reidlinger, AKTN, University of Queensland
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. The use of lanthanum carbonate to reduce phosphate and calcium-phosphate product may improve arterial compliance and attenuate the development and/or progression of vascular calcification, reduce the incidence of secondary hyperparathyroidism, and potentially reduce the rate of CKD progression.488 patients with CKD stage 3b and 4 (eGRF 15-45 ml/min/1.73m2), with a urinary albumin/creatinine ration of > 10 mg/mmol and a serum phosphate >1.20 mmol/L who are 18 or more years of age and able to give informed consent will be recruited to the trial, and randomised to receive one 500mg tablet lanthanum carbonate tablets 3x daily, or placebo. Participants will be followed every 12 weeks for 48 months, and assessed for arterial compliance; aortic calcification; serum levels of phosphate, calcium, Ca x P, parathyroid hormone and FGF-23; renal function and bone mineral density at the lumbar spine.
This trial is being fully coordinated through the Australasian Kidney Trials Network (Trial no. AKTN 10.01). Contact for more information, or call +61 (0)7 3176 5961.
This trial is also being conducted in parallel in the United Kingdom, through the UK Kidney Research Consortium.
Ace inhibition for the preservation of renal function and patient survival in kidney transplantation
Local (ANZ) title: The ‘AVATAR’ Trial: Ace inhibitors Versus plAcebo Therapy After Renal transplantation
Controlled-trials.com trial registration number: MCT-78844
Principal Investigator: Dr Greg Knoll, Ottawa Hospital Research Institute
Local (ANZ) Principal Investigator: Dr Helen Pilmore, Auckland City Hospital, NZ
Clinical Research Associate: Dr Michael Watson, Australasian Kidney Trials Network, University of Queensland
The AVATAR Trial is a multi-centre, double-blind, randomised controlled trial comparing the ACE inhibitor ramipril to placebo in 528 renal transplant recipients with chronic kidney disease defined by reduced glomerular filtration rate and the presence of proteinuria. The trial is designed to determine if ramipril is superior to placebo in decreasing the time to doubling of serum creatinine or renal transplant failure (defined as return to dialysis or repeat transplantation) or death.
Renal transplant recipients who: a) have an estimated glomerular filtration rate > 20 ml/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) study equation which has been validated in renal transplant patients; b) have proteinuria ≥ 0.2 grams/day; c) are at least three months post-transplantation; d) have signed informed consent will be randomised to receive Ramipril (10 mg daily) or matched placebo.
This trial is being led by Dr Greg Knoll through Ottawa Hospital Research Institute in Canada. The AKTN is facilitating the Australian and New Zealand arm of the trial. 528 patients will be randomised across all sites, and followed from between 2 and 4 years.
Contact for more information, or call +61 (0)7 3176 5349
The SOLID Trial: A randomised, controlled trial of low sodium dialysate versus conventional sodium dialysate to reduce left ventricular mass index in patients receiving home haemodialysis:
SOLID: The SOdium Lowering In Dialysate Trial
Australian and New Zealand Clinical Trials Registry number: 12611000975998
Principal Investigator: Dr Mark Marshall, Centre for Clinical Research and effective practice (CCRep), Middlemore, New Zealand.
Clinical Project Manager: Ms Lynda Mockett, Centre for Clinical Research and effective practice (CCRep), Auckland, New Zealand.The primary aim of the SOLID trial is to assess whether low dialysate [Na+] improves left ventricular structure in patients receiving home haemodialysis (HD). The primary outcome is left ventricular mass index (LVMI) as measured by cardiac magnetic resonance image (MRI) scanning. The secondary aims are to assess whether low dialysate [Na+] improves other surrogate cardiovascular outcomes and potential mechanistic factors: left ventricular function and haemodynamics, blood pressure, extra-cellular fluid volume status, thirst, and inter-dialytic weight gain. In addition, the SOLID trial will test low dialysate [Na+] in terms of tolerability and effect on health-related quality of life.
The trial will recruit 118 participants on home HD over the age of 18 years from five New Zealand centres. After baseline measurements including a cardiac MRI scan, participants will be randomised to receive low dialysate [Na+] of 135mM or conventional dialysate [Na+] of 140mM. Following randomisation, participants will undergo a supervised change in dialysate [Na+] by increments or decrements of 1mM/week until their target dialysate [Na+] has been achieved. Patients will be maintained on this dialysate setting until the 12 month follow-up.
The effect of low dialysate [Na+] on LVMI will be assessed by a repeat cardiac MRI scan at 12 months follow-up. Other outcomes will be assessed by blinded assessors at variably 3, 6, 9 and 12 months follow-up.
The trial is funded by the Health Research Council of New Zealand and endorsed by the Australasian Kidney Trials Network. It is being fully coordinated through The Centre for Clinical Research and effective practice (CCRep), Auckland, New Zealand.
Contact Mark R Marshall (mrmarsh@woosh.co.nz) for further information.