Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.

BAY 85-3934 (molidustat) induced the transcription of hypoxia-sensitive genes in HeLa, A549, and Hep3B cells. The mRNA expression levels of a panel of HIF target genes were analyzed by quantitative RT-PCR (qRT-PCR) in the three cell lines 4 h after exposure to concentrations of BAY 85-3934 up to 10 µM. mRNA levels were found to be induced by BAY 85-3934 in a dose-dependent manner. The basal level of expression and the factor of induction varied considerably between cell lines. The highest induction factors (up to 20-fold) were observed for carbonic anhydrase IX (CA-IX) in HeLa cells, CA-IX and angiopoietin-like 4 (ANGPTL-4) in A549 cells, and EPO and ANGPTL-4 in Hep3B cells. The other genes examined were induced between 2- and 5-fold. The mRNA expression level of ANGPTL-4 was not increased by BAY 85-3934 in HeLa cells. EPO mRNA was not detectable at baseline and not induced in HeLa or A549 cells. The threshold concentration for induction of CA-IX expression was 500 nM in HeLa cells, and greater than 1 µM for all other genes that showed a response.