Therapeutic methods using vadadustat
This invention provides methods for the treatment of anemia in patients with chronic kidney disease (CKD) using vadadustat (Compound 1). Methods described herein provide alternative dosing regimens for patients having anemia. In addition, methods herein are suitable for patients converting from a previous anemia treatment including erythropoietin stimulating agent (ESA), patients who are on dialysis (e.g., peritoneal dialysis or hemodialysis), or CKD patients having certain hemoglobin (Hb) levels.
1 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg to about 1800 mg of Compound 1 three times weekly.
2 . The method according to claim 1 , wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
3 . The method according to claim 1 , wherein the hemoglobin levels are maintained at about 10.0 g/dL to about 13.0 g/dL.
4 . The method of claim 1 , wherein the patient has anemia secondary to or associated with chronic kidney disease (CKD).
5 . The method of claim 4 , wherein the CKD is dialysis-dependent CKD (DD-CKD).
6 . The method of claim 1 , wherein the patient previously has been treated with an erythropoietin stimulating agent (ESA), wherein the ESA is epoetin, darbepoetin alfa (DA), or methoxy polyethylene glycol-epoetin beta (epoetin beta pegol).
7 . The method of claim 1 , wherein hemoglobin levels are maintained at about 10.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 11.0 g/dL to about 13.0 g/dL.
8 . The method of claim 7 , wherein the hemoglobin levels are maintained at about 11.0 g/dL to about 12.0 g/dL, or the hemoglobin levels are maintained at about 10.0 g/dL to about 11.0 g/dL.
9 . The method of claim 8 , wherein the dose is administered to the patient for at least about 12-260 weeks.
10 . The method of claim 9 , wherein the dose is administered to the patient for at least about 12 weeks, for at least about 24 weeks, for at least about 28 weeks, for at least about 32 weeks, for at least about 36 weeks, for at least about 40 weeks, for at least about 44 weeks, for at least about 48 weeks, for at least about 52 weeks, for at least about 64 weeks, for at least about 76 weeks, for at least about 88 weeks, for at least about 104 weeks, for at least about 116 weeks, for at least about 128 weeks, for at least about 140 weeks, for at least about 156 weeks, for at least about 168 weeks, for at least about 180 weeks, for at least about 192 weeks, for at least about 208 weeks, or for at least about 260 weeks.
11 . The method of claim 1 , wherein the dose comprises about 750 mg to about 1200 mg of Compound 1 three times weekly.
12 . The method of claim 1 , wherein the dose comprises about 750, 900, 1200, 1350, 1500, 1650, or 1800 mg of Compound 1 three times weekly.
13 . The method of claim 4 , wherein the CKD is non-dialysis dependent CKD (NDD-CKD).
14 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, for at least about 12 to about 260 weeks, wherein the dose comprises about 750 mg-1800 mg of Compound 1 three times weekly.
15 . The method of claim 14 , wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
16 . The method of claim 15 , wherein the hemoglobin levels are maintained at about 10.0-13.0 g/dL.
17 . The method of claim 14 , wherein the dose comprises about 750-1200 mg of Compound 1 three times weekly.
18 . A method of treating anemia, comprising administering to a patient having anemia a dose of a compound that is {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid having the structure of Compound 1,
or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the dose comprises about 750 mg-1800 mg of Compound 1 three times weekly, wherein the patient was previously treated with an erythropoietin stimulating agent (ESA), and wherein anemia is anemia associated with or secondary to dialysis-dependent chronic kidney disease (DD-CKD).
19 . The method of claim 18 , wherein the hemoglobin levels are increased to about at least 10 g/dL from a baseline hemoglobin level.
20 . The method of claim 19 , wherein hemoglobin levels are maintained at about 10.0-13.0 g/dL.
21 . The method of claim 18 , wherein the dose comprises about 750-1200 mg of Compound 1 three times weekly.