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news.New York City-based Keryx Biopharmaceuticals has started phases III and IV of its clinical program for KRX-101, its drug candidate for the treatment of diabetic nephropathy.
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The company said the phase III segment is a randomized study that will compare 200mg daily of KRX-101 versus placebo in 1,000 patients with persistent microalbuminuria.
The phase IV part will conduct the same trial with 2,200 patients suffering from persistent macroalbuminuria or overt nephropathy.
The program is being conducted by The Collaborative Study Group (CSG), a renal clinical trial group, and will be led by its co-chairman Edmund Lewis. More than 250 US, European and Asian-Pacific clinical centers are participating in the KRX-101 studies.
Keryx hopes to launch the drug in late 2007.