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.
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.