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 have shown that Ferinject ( Ferric carboxymaltose ) targeting a serum ferritin of 400-600 mcg/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 greater than or equal to 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.
FIND-CKD is the largest and longest prospective, randomised clinical trial ever conducted comparing intravenous 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 mcg/L ) or lower ( 100–200 mcg/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 mcg/L significantly reduced or delayed the need for alternative anaemia management or the occurrence of two consecutive haemoglobin ( Hb ) levels less than 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 has demonstrated 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 CKD that recommend a trial of Iron therapy if an increase in haemoglobin without ESA therapy is desired in patients with ND-CKD and iron deficiency anaemia.
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 non-dialysis-dependent chronic kidney disease, and may improve and simplify the quality of care in these patients. ( Xagena )
Source: Vifor Pharma, 2013