Trials in Development
The following trials have been approved by the AKTN Scientific Committee approvals process for coordination, facilitation or endorsement by the AKTN, as appropriate. The legal, ethical, regulatory and logistical processes are currently being finalised. Once all of these processes are completed, the trials will become active and start recruiting participants.
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 ‘TransDiab’ Trial: A randomised controlled trial of metformin versus gliclizide in overt diabetes and and metformin versus placebo in glucose intolerance in the treatment of new onset diabetes after kidney transplantation (NODAT): Feasibility study
Australian and New Zealand Clinical Trials Registry number: (TBA)
Principal Investigator: Dr Helen Pilmore, Auckland City Hospital, NZ
Clinical Research Associate: TBA, AKTN, University of Queensland
This trial aims to investigate the potential benefits of metformin for the treatment and prevention of post-transplant diabetes mellitus. Although this treatment has been demonstrated to be effective in the general population, it has not been trialed in the transplant population. The first component of this trial will be a feasibility study to assess the tolerability and safety of metformin in this patient population. Several face-to-face meetings have been held with opinion leaders in the Transplantation community, and significant progress has been made towards finalising the protocol. The AKTN aims to initiate the TransDiab trial during 2012.
Contact for more information, or call +61 (0)7 3176 5821.
The CKD-FIX Study: a randomised Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase).
Australian and New Zealand Clinical Trials Registry number: 12611000791932
Principal Investigator: Prof David Johnson, Department of Nephrology, Princess Alexandra Hospital, Brisbane Qld
Clinical Research Associate: TBA, AKTN, University of Queensland
The primary aim of the study is to test the hypothesis that uric acid lowering therapy with the xanthine oxidase (XO) inhibitor, allopurinol, will significantly slow kidney failure progression in patients with moderate chronic kidney disease (CKD). 620 adult participants with CKD stages 3 or 4 who have experienced rapid progression of their CKD over the preceding 12 months will be recruited to the trial. Participants will be randomised 1:1 to receive 100-200 mg of allopurinol daily (dose dependent on CKD stage), and treatment will be blinded to participant and treating team. The primary outcome measure will be an assessment of eGFR throughout and at the end of the 24 month treatment period as a marker of CKD progression, and a series of secondary outcomes related to blood pressure, proteinuria, cardiovascular events and death will also be measured.
Funding has been applied for, with hopes to launch the trial during 2012.
This trial has been approved by the Scientific Committee for full coordination through the Australasian Kidney Trials Network (Trial no. AKTN 10.01), assuming adequate funding is received. Contact for more information.
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 and will launch in 2012.
Contact Mark R Marshall (mrmarsh@woosh.co.nz) for further information.