Oxpentifylline Versus Placebo in the Treatment of Erythropoietin-resistant Anaemia: A Randomized Controlled Trial

David Wayne Johnson; Carmel Mary Hawley; Brenda Rosser; Elaine Beller; Charles Thompson; Robert G Fassett; Paolo Ferrari; Stephen MacDonald; Eugenie Pedagogos; Alan Cass


BMC Nephrology 

In This Article


This invesigator-initiated, multicentre Australian and New Zealand study has been designed to provide evidence to help nephrologists and their CKD patients better determine whether Oxpentifylline (Trental®) administration will safely and effectively treat erythropoietin- or darbepoietin-resistant anaemia. Given that numerous studies have demonstrated that ESA hyporesponsive patients are at significantly increased risk of mortality,[28] novel treatments for correcting anaemia in this group (such as with oxpentifylline) may represent an important strategy for improving clinical outcomes. The multicentre nature of the trial will greatly enhance its generalisability. Moreover, the trial sample size has been carefully and prospectively calculated using a minimum clinically important difference in haemoglobin level of 10 g/L and realistic estimates of trial drop-out and non-compliance rates to minimise the risk of a type 2 statistical error. Demonstration of a significant improvement in haemoglobin levels with oxpentifylline therapy will provide clinicians with an important new strategy for effectively treating ESA-resistant anaemia. On the other hand, a negative study will dissuade clinicians from unnecessarily exposing patients to oxpentifylline (which has a small potential for side effects) if it is proven to lack efficacy with respect to treating ESA-resistant anaemia.


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