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Kidney Week

Abstract: FR-PO1165

Safety and Effectiveness of Ferric-Carboxymaltose in Kidney Transplant Patients

Session Information

Category: Transplantation

  • 1902 Transplantation: Clinical

Authors

  • Apicella, Luca, University Hospital "San Giovanni di Dio e Ruggi d'Aragona" of Salerno - Italy, Salerno, Italy
  • Bellizzi, Vincenzo, University Hospital "San Giovanni di Dio e Ruggi d'Aragona" of Salerno - Italy, Salerno, Italy
  • Secondulfo, Carmine, University Hospital "San Giovanni di Dio e Ruggi d'Aragona" of Salerno - Italy, Salerno, Italy
  • Palladino, Giuseppe, University Hospital "San Giovanni di Dio e Ruggi d'Aragona" of Salerno - Italy, Salerno, Italy
  • Bilancio, Giancarlo, University Hospital "San Giovanni di Dio e Ruggi d'Aragona" of Salerno - Italy, Salerno, Italy
Background

In kidney transplant patients (KTx), the post-transplant anemia (PTA) is associated with worst graft outcome and increased cardiovascular/all causes mortality. With common available iron treatments, iron deficiency (ID) in KTx is highly prevalent and represents one of the major causes of PTA. This prospective study evaluates the safety and effectiveness of ferric-carboxymaltose (FCM) in KTx patients with iron deficiency anemia (IDA) and no/low response to other previous iron treatment.

Methods

Consecutive, stable (tx age > 1-y), CKD-3/5 stages, anemic (Hb <11g/dl and/or ESA treatment), iron deficiency (TSAT <20% and/or ferritin <100 ng/ml), previous iron intolerance or low-responce, KTx were prospectively enrolled. Each patient was administered FCM, 500 mg, in standardized conditions at baseline, and eventually a second dose 500 mg dose one month later. Patients were evaluated for clinical conditions, iron status, anemia and renal function every month during a 6-months follow-up (irrespective of iron administration). Clinical and lab side-effects FCM related (nausea, vomiting, diarrhea, headache, fever, rush, erythema, itching, myalgia, bronchospasm, anaphylaxis) were monitored during the study.

Results

32 KTx (M15-F17); Diabetes: 19%; Age: 55.8±11.7years; BMI: 26.3±4.5 kg/m2; transplant age: 104±92 months; eGFR: 38.2±11.9 ml/min; SBP:135±21, DBP:81±12 mmHg; ACEi/ARB:28.1%; previous iron: naïve, n=7 (reported intolerance during dialysis), os, n=20 (16 ongoing), i.v., n=4 (0 ongoing). At 34±4 days after FMC infusion, ferritin increased from 44±53 to 149±136 ng/mL (p<0.001), TSAT from 10±6 to 18±10% (p<0.001), Hb from 10.2±1.0 to 11.3±1.4 g/dl (p<0.01); at 160±71 days, ferritin was 93±110 ng/mL, TSAT 19±9% and Hb 12.0±1.7 g/dl (all p<0.05 vs Baseline and NS vs 34days). At baseline, 81% of pts were on ESA at a mean dose of 9.960±6.620; during the follow-up, pts on ESA reduced to 75% and 44% and ESA dose to 10.480±9.670 and 6.760±11.220 IU/week, respectively. No changes of clinical parameters, renal function or electrolytes occurred; no side effect was detected.

Conclusion

In stable KTx patients with iron deficiency related anemia, the treatment with FCM is safe and effective, even in subjects resistant to previous iron treatment, allowing an optimal and stable correction of both iron deficiency or anemia, while reducing the ESA dose.

Funding

  • Private Foundation Support