Mircera two month treatment cycle found to correct anaemia in chronic kidney disease
Results from two Roche studies show for the first time that chronic kidney disease patients on dialysis as well as those not on dialysis who need correction of renal anaemia, can be successfully treated with Mircera on a simple twice monthly dosing schedule.
Mircera was shown to be as effective as existing agents in correcting renal anaemia while reducing the dosing frequency 2 to 6-fold of these drugs. Two phase III trials demonstrating these findings were presented at the 39th annual meeting of the American Society of Nephrology in San Diego, USA.
"There is no doubt that Mircera is very effective at correcting anaemia," said Dr. Iain Macdougall, consultant Nephrologist and Honorary Senior Lecturer at King's College Hospital in London and an investigator in the ARCTOS trial. "We were pleased to see a smooth rise in, and stable control of, haemoglobin at these initial dosing intervals of twice a month. It is important with new patients being treated for the first time to feel confident in carefully managing their rise in haemoglobin."
Mircera the first and only Continuous Erythropoietin Receptor Activator (CERA.), is a new drug under development for the treatment of anaemia in patients with CKD. Roche filed applications with regulatory authorities in the EU and the US in April this year seeking approval for use of the treatment in anaemia associated with CKD in patients on dialysis and not on dialysis.
"Effective elevation and predictable control of haemoglobin are key to managing renal anaemia, improving physical functioning and reducing the risk of complications," said Robert Provenzano, chief, division of nephrology, hypertension and transplantation, St. John Hospital and Medical Centre in Detroit, Michigan and an investigator with one of the US-based clinical trial sites for ARCTOS. "These results show Mircera may provide doctors with a way to manage anaemia with less frequent dosing."
Renal anaemia is a common and debilitating complication of CKD that's characterized by a low concentration of haemoglobin (Hb) in the blood. Inadequate Hb levels deprive the body's tissues of oxygen and can lead to serious cardiovascular complications and even death if left untreated.