Communiqué de presse

Ferinject® reduces or delays requirement for alternative anaemia management compared with oral iron therapy: FIND-CKD study presented at the American Society of Nephrology (ASN) Kidney Week

Lundi 11 novembre 2013, ↓ accès direct au téléchargement

Results from the FIND-CKD study were presented at the American Society of Nephrology (ASN) Kidney Week in Atlanta, Georgia, USA. The FIND-CKD results demonstrate that Ferinject® (ferric carboxymaltose) targeting a serum ferritin of 400-600 µg/L in patients with non-dialysis-dependent chronic kidney disease (ND-CKD) and iron deficiency anaemia significantly reduces or delays the need for alternative anaemia management (such as erythropoiesis-stimulating agents (ESAs) or blood transfusion). Ferinject® also results in a faster haemoglobin response with a greater proportion of patients achieving a Hb increase ≥1 g/dL. Furthermore, intravenous (i.v.) Ferinject® was shown to be well-tolerated with fewer treatment-related adverse events and study discontinuations compared to oral iron.

“The question of whether intravenous iron therapy is an appropriate first-line therapy in patients with ND-CKD is currently an issue of intense debate. FIND-CKD is the largest and longest study of intravenous versus oral iron therapy without ESA in this patient population. It is also the first such trial that uses requirement for alternative anaemia management as the primary endpoint rather than haemoglobin. While the FIND-CKD study achieved its primary endpoint and is of importance to clinicians who treat patients with ND-CKD, I believe that the findings could have wider implications for the management of iron deficiency anaemia in other settings such as surgery, gynaecology and oncology,” commented Iain Macdougall, Consultant Nephrologist and Professor of Clinical Nephrology at King's College Hospital in London, UK.

FIND-CKD is the largest and longest prospective, randomised clinical trial ever conducted comparing intravenous (i.v.) versus oral iron for the treatment of iron deficiency anaemia in patients with ND-CKD who were not receiving ESA therapy. More than 600 patients from 20 countries were included in this 56-week clinical study. Patients were randomised to receive Ferinject® targeting a higher (400–600 µg/L) or lower (100–200 µg/L) serum ferritin level, or oral iron. The study met its primary endpoint, demonstrating that Ferinject® given at a starting dose of 1,000 mg with subsequent dosing as required to maintain a serum ferritin of 400–600 µg/L significantly reduced or delayed the need for alternative anaemia management or the occurrence of two consecutive haemoglobin (Hb) levels <10 g/dL compared to oral iron. These results were achieved with in average four Ferinject® injections only.

Ferinject® was well-tolerated with fewer treatment-related adverse events, no renal toxicity, and no increase in cardiovascular or infectious events. In addition, intolerance in patients receiving oral iron led to significantly more study discontinuations than in patients receiving Ferinject®. FIND-CKD demonstrates that Ferinject® without ESA therapy is a well-tolerated and an effective treatment for iron deficiency anaemia in patients with ND-CKD.

To date, there has been limited evidence from sufficiently large and long-duration studies regarding the relative efficacy and safety of intravenous versus oral iron therapy in patients with ND-CKD and iron deficiency anaemia. In addition, iron therapy based on different serum ferritin targets has not been previously studied. The results from FIND-CKD provide evidence to support current anaemia guidelines in CKD1 that recommend a trial of iron therapy if an increase in Hb without ESA therapy is desired in patients with ND-CKD and iron deficiency anaemia2. These data also demonstrate that treatment with Ferinject® targeting a higher serum ferritin level is an effective, well-tolerated and convenient therapy for iron deficiency anaemia in patients with ND-CKD, and may improve and simplify the quality of care in these patients.

Vifor Pharma, une entreprise du Groupe Galenica, est l’un des leaders mondiaux en matière de découverte, développement, fabrication et commercialisation de produits pharmaceutiques utilisés dans le traitement de la carence en fer. La société propose également un portefeuille diversifié de produits de prescription et de produits délivrés sans ordonnance (OTC). Vifor Pharma, dont le siège est à Zurich (Suisse), étend sans cesse sa présence mondiale et dispose d’un vaste réseau de filiales et de partenaires dans le monde.

Ferinject® is an innovative non-dextran intravenous (i.v.) iron replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® (US brand name: Injectafer®) has gained marketing authorisation in 53 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other diseases. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further clinical trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women’s health are ongoing.

FIND-CKD (Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease) is a large, open-label, multi-centre, randomised, 3-arm clinical trial designed to investigate the comparative efficacy and safety of intravenous (i.v.) Ferinject® (ferric carboxymaltose) versus oral iron for the treatment of iron deficiency anaemia in patients with non-dialysis-dependent chronic kidney disease (ND-CKD). The study met its primary endpoint thereby demonstrating that i.v. Ferinject® is superior to oral iron therapy in reducing the need for other anaemia management (e.g. erythropoiesis-stimulating agents (ESAs) or blood transfusion) in ND-CKD patients with iron deficiency anaemia.

626 patients with ND-CKD (eGFR <60mL/min/1.73 m2) who had not received ESA therapy in the last 4 months and were diagnosed with iron deficiency anaemia (Hb 9-11g/dL and serum ferritin <100ng/mL or serum ferritin <200ng/mL with TSAT <20%) were randomized in the study.

Patients were randomized in a 1:1:2 ratio to one of three treatment arms:
1st arm: 1,000mg iron as i.v. Ferinject® targeting a serum ferritin = 400 – 600µg/L
2nd arm: 200mg iron as i.v. Ferinject® targeting a serum ferritin = 100 – 200µg/L
3rd arm: Daily oral iron (200mg elemental iron)

The primary endpoint was first time to initiation of other anaemia management or two consecutive Hb values <10g/dL without an Hb increase of >0.5g/dL.

References
1. KDIGO Clinical Practice Guideline for Anaemia in Chronic Kidney Disease. Kidney International Supplements 2012:2(4);283–87.
2. Locatelli F, Bárány P, Covic A, et al. Kidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: a European Renal Best Practice position statement. Nephrol Dial Transplant 2013;28:1346–59.

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Beatrix Benz

Head of Global Communications & Public Affairs


Vifor Pharma Ltd.

Global Communications
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CH-8152 Glattbrugg

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