Press release

FIND-CKD study demonstrates that Ferinject® reduces need for alternative anaemia treatment

Wednesday, 10 July 2013, ↓ directly to download

The FIND-CKD study was designed to investigate the optimal route of administration and dosing strategy for iron therapy in patients with non-dialysis-dependent chronic kidney disease (ND-CKD) suffering from iron deficiency anaemia. Ferinject® (ferric carboxymaltose) was compared to oral iron treatment. The study met its primary endpoint, thereby demonstrating that Ferinject® reduces the need for other anaemia management (e.g. erythropoiesis-stimulating agents (ESAs) or blood transfusion) in this patient population.

FIND-CKD is the largest and longest study ever conducted in patients with ND-CKD to assess the efficacy and long term safety of intravenous (i.v.) iron for the treatment of iron deficiency anaemia (IDA). More than 600 patients from 20 countries were included in this 56-week clinical trial.
The study met its primary endpoint thereby demonstrating that i.v. Ferinject® given at a starting dose of 1,000mg and subsequent dosing as required to maintain guideline-specified serum ferritin levels significantly prolongs the time until other anaemia management is needed in ND-CKD patients with iron deficiency anaemia.

While several small studies have assessed the optimal route of administration and dosing strategy for iron therapy in patients with ND-CKD, rigorous data are still sparse and, therefore, treatment schemes for the management of IDA vary widely. Hence, the results of FIND-CKD could represent a significant advance in the understanding of how to best treat ND-CKD patients with IDA.

It is important to identify and effectively treat iron deficiency anaemia in patients with ND-CKD, because IDA is associated with an increased risk of progression to end-stage renal disease, cardiovascular events and death in these patients 1,2,3. Furthermore, the risk for anaemia increases as renal function deteriorates and it is estimated that as many as 70% of patients with ND-CKD are anaemic by the time they reach dialysis 4. Iron deficiency is the most common cause of anaemia in patients with ND-CKD and it has been estimated that 60-70% of all patients with ND-CKD are iron deficient 5. Iron deficiency limits effective erythropoiesis and is also the main cause of hyporesponsiveness to therapy with erythropoiesis-stimulating agents (ESAs) 6,7,8.

Detailed results of the study will be submitted for presentation at the American Society of Nephrology (ASN) Kidney Week taking place in Atlanta, Georgia, USA, from November 5 - 10, 2013. In addition, publication in a peer-reviewed journal is also being planned.

Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.

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® has gained marketing authorisation in 46 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 ferritin < 100ng/mL or 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 ferritin = 400 - 600ng/mL
2nd arm: 200mg iron as i.v. Ferinject® targeting a ferritin = 100 - 200ng/mL
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. Fishbane S. Anemia and cardiovascular risk in the patient with kidney disease. Heart Fail Clin 2008; 4:4 01-410.
2. Kovesdy CP, Trivedi BK, Kalantar-Zadeh K, Anderson JE. Association of anemia with outcomes in men with moderate and severe chronic kidney disease. Kidney Int 2006; 69: 560-564.
3. Thorp ML, Johnson ES, Yang X, Petrik AF, Platt R, Smith DH. Effect of anaemia on mortality, cardiovascular hospitalizations and end-stage renal disease among patients with chronic kidney disease. Nephrology (Carlton) 2009; 14: 240-246.
4. Valderrábano F, Hörl WH, Macdougall IC, et al. PRE-dialysis survey on anaemia management. Nephrol Dial Transplant 2003; 18: 89-100.
5. Fishbane S, Pollack S, Feldman H, Joffe M. Iron Indices in Chronic Kidney Disease in the National Health and Nutritional Examination Survey 1988–2004. Clin J Am Soc Nephrol. 2009; 4: 57–61.
6. Hörl WH. Non-erythropoietin-based anaemia management in chronic kidney disease. Nephrol Dial Transplant 2002; 17(Suppl 1): 35-38.
7. Fishbane S, Frei GL, Maesaka J. Reduction in recombinant human erythropoietin doses by the use of chronic intravenous iron supplementation. Am J Kidney Dis 1995; 26: 41-46.
8. Sunder-Plassmann G, Hörl WH. Importance of iron supply for erythropoietin therapy. Nephrol Dial Transplant 1995; 10: 2070-2076.

Contact

Beatrix Benz

Head of Global Communications & Public Affairs


Vifor Pharma Ltd.

Global Communications
Flughofstrasse 61
P.O. Box
CH-8152 Glattbrugg

Phone:
+41 58 851 80 00
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+41 58 851 80 01

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