P1753EFFECTIVENESS AND TOLERABILITY OF 500 MG-I.V. FERRIC CARBOXYMALTOSE FOR THE TREATMENT OF IRON DEFICIENCY IN PATIENTS WITH KIDNEY TRANSPLANT
Authors: Soragna Giorgio , Rodofili Amelia , Tricerri Alberto , Ramondetti Ada , Gerbino Gianfranca , Vitale Corrado 
Published: June 2020

Abstract

Background and Aims
Post transplantation anaemia (PTA) is a common finding in kidney transplant patients, with reported prevalence ranging from 25 to 40%, and it is associated with adverse outcomes for the kidney allograft and the recipient. The pathogenesis of PTA is multifactorial, including iron deficiency, reduced graft function, untoward effects of drugs (immunosuppressants, ACE-I and ARB), folic acid and vitamin B12 deficiency, inflammatory states.
Ferric carboxymaltose (FCM) reportedly improved haemoglobin (Hb) levels and replenished depleted iron stores in various populations of patients with iron-deficiency anaemia, but there are few data about its use in PTA.
In this study we evaluated the effectiveness and tolerability of high intravenous doses of FCM (500 mg) for the treatment of iron deficiency and anaemia in patients with kidney transplant.

Method
Absolute iron deficiency was considered as transferrin saturation (TSAT) less than 20% with ferritin levels below 100 µg/L. Anaemia was defined as Hb&lt;13 g/dL in males and Hb&lt;12 g/dL in females.
Out of 101 patients with kidney transplant, 56 presented with absolute iron deficiency (59±13 years old, M/F=0.95, 8±4.6 years of transplantation; serum creatinine 1.45±0.64 mg/dL): of these, 40 patients had anaemia (7 were also taking ESAs) and 16 had normal Hb levels.
The 16 patients with absolute iron deficiency and normal Hb were not prescribed iron supplements, fearing of causing erythrocytosis, whereas 36 of 40 patients with anaemia and iron deficiency were given FCM 500 mg, as i.v. infusion for 30 minutes.
Hb, ferritin and TSAT were assayed either before and 45-60 days after FCM supplementation, which was repeated if Hb levels were less than 0.5 g/dL below the normal value. Data were reported as mean±SD.

Results
Among the 56 patients with absolute iron deficiency, there were not any significant differences in serum levels of folic acid and vitamin B12 between those with and without anaemia (p=ns).
After the first dose of FCM, in 36 patients with iron deficiency and anaemia, ferritin levels increased from 55±69 ng/mL to 111±107 ng/mL (p&lt;0.01), TSAT increased from 12.2±5.9% to 20.4±10.3% (p&lt;0.01) and Hb increased from 10.9±0.9 g/dL to 12.3±1.3 g/dL (p&lt;0.01). Furthermore, 24/36 patients (67%) no longer had absolute iron deficiency and 19/36 (53%) were not anaemic anymore.
Out of the 17 patients still showing anaemia after the first FCM dose, 10 had Hb levels less than 0.5 g/dL below the normal value and were given a second dose of FCM. In this subset, Hb level increased on average from 11.4±0.5 g/dL to 12±0.9 g/dL (p&lt;0.01) and became normal in 3 patients.
After the FCM course, in 2 out of 7 patients ESAs were discontinued, whereas in 3 patients their doses were reduced and in 2 patients remained unchanged.
Only one patient had an adverse effect during FCM infusion, namely, a transient skin flushing on her face during the second dose, which immediately remitted when the infusion was interrupted.

Conclusion
In patients with PTA and absolute iron deficiency, single or repeated doses of 500 mg of i.v. FCM were effective in improving Hb levels, well tolerated and reduced the need for ESAs.
Of 56 patients with kidney transplant and absolute iron deficiency, 16 (28%) had normal Hb levels. We did not treat such subjects, fearing of causing erythrocytosis. However, given that iron deficiency may affect negatively both heart and muscle metabolism, what is the best management of iron deficiency in transplanted patients without anaemia is still an open question.