COMPLICATIONS - CARDIOVASCULAR

D.W. Mudge¹, K. Tan¹, R. Miles², D.W. Johnson¹, S.B. Campbell¹, C.M. Hawley¹, N.M. Isbel³, C.L. Van eps³, D.L. Nicol^4
1Department Of Nephrology, University of Queensland at Princess Alexandra Hospital, Brisbane/AUSTRALIA, ²Department Of Renal Medicine, Greenslopes Private Hospital, Brisbane/QLD/AUSTRALIA, ³Department Of Nephrology, University of Queensland at Princess Alexandra Hospital, Brisbane/QLD/AUSTRALIA, ⁴Department Of Urology, University of Queensland at Princess Alexandra Hospital, Brisbane/QLD/AUSTRALIA

Body: Introduction: Post-transplant anemia remains a common problem after kidney transplantation, with an incidence ranging from nearly 80% at day 0 to about 25% at 1 year. It has been associated with poor graft outcome, and recently has also been shown to be associated with increased mortality. We had noticed that 2 patients incidentally given intravenous iron doses and then co-incidentally called for kidney transplant had not experienced significant anemia after transplantation, and hypothesised that intravenous iron might be superior to oral iron for this purpose. The aim of this trial was to compare a peri-operative single dose of intravenous (IV) iron with continuous oral iron (PO) for the treatment of post-transplant anemia in new kidney transplant recipients at our hospital. Methods: This is an investigator-initiated open label, randomised controlled trial of IV versus PO iron supplementation in kidney transplant recipients involving 100 patients recruited over a 15-month period. Patients were randomised to receive a single dose of 500 mg iron polymaltose given within a few days of transplantation, or 2 ferrous sulphate slow-release tablets daily from the time of hospital discharge (day 5 to 7). The primary outcome measure was time to resolution of anemia, defined as hemoglobin ≥11 g/L. Prospective power calculations had shown a sample size of 48 patients per group would be required to have 90% chance of detecting a halving of the time to resolution of anemia in the IV as compared to the PO group. Secondary outcomes included significant infections, blood transfusion requirements, severe gastrointestinal side effects related to iron, and acute rejection episodes. Exclusion criteria included iron overload (ferritin >800 µg/L or transferrin saturation > 50%) or previous intolerance of oral or intravenous iron. The trial was registered with the Australian and New Zealand Clinical Trials Registry, and study protocol published in BMC Nephrology in 2009. Results: 100 patients were recruited and 98 had complete data for analysis. The mean age was 46 years and 72% were male. There was no significant difference in the time to Hb ≥11 g/L comparing IV with PO iron (HR 1.22; 95% CI 0.82 – 1.83; p= 0.32). The median time to hemoglobin ≥11 g/L was 12 days in the IV group vs. 21 days in the PO group. There were no differences in adverse events between the groups including infections (10 IV vs 12 PO, p=0.62), and acute rejection (4 IV vs 3 PO, p=0.68). There were numerically fewer patients in the IV group requiring transfusions (5 vs 9) or suffering severe gastrointestinal side-effects (3 vs 6) compared to the PO group, although neither of these results were statistically significantly different (p=0.24 and 0.29 respectively) due to low event rates. Conclusion: A single dose of intravenous iron given peri-operatively was a safe and effective alternative to oral iron replacement in new kidney transplant recipients, although was not associated with a shorter period of post-transplant anemia or a significant reduction in severe gastro-intestinal side-effects compared to oral iron.

Disclosure: All authors have declared no conflicts of interest.