Claims for Patent: 12,582,631

Summary for Patent: 12,582,631

Title:	Methods of improving renal function
Abstract:	Provided herein are methods of improving kidney function in a subject in need thereof.
Inventor(s):	Philip Thomas Frohlich, Andrew James KING, Chidambaram Ramachandran, Sarah Beth Noonberg
Assignee:	Chinook Therapeutics Inc
Application Number:	US17/888,766
Patent Claims:	1. A method of causing a reduction in proteinuria in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, wherein the subject has been previously diagnosed with IgA nephropathy and wherein the diagnosis of IgA nephropathy comprises a kidney biopsy, detecting anti-glycan antibodies, detecting deposition of IgA-immune complexes in the kidney, or a combination of any of the foregoing, wherein the subject has proteinuria of less than 1 g/day in at least two of three consecutive readings after initiation of administration of a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, and wherein the IgA nephropathy is primary IgA nephropathy. 2. The method of claim 1, wherein the subject has been determined to have proteinuria of at least 1 g/day prior to initiation of administration of a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof. 3. The method of claim 1, wherein proteinuria is reduced by about 10% to about 99% after administration of a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, relative to the proteinuria prior to initiation of administration of a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof. 4. The method of claim 3, wherein proteinuria is reduced by about 20% to about 80% in the subject after administration of a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, relative to the proteinuria prior to initiation of administration of a therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof. 5. The method of claim 1, wherein proteinuria comprises albuminuria. 6. The method of claim 1, wherein the therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, is from about 0.20 mg to about 1.5 mg of atrasentan, or an equivalent amount of a pharmaceutically acceptable salt thereof. 7. The method of claim 1, wherein the therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, is from about 0.40 mg to about 0.85 mg of atrasentan, or an equivalent amount of a pharmaceutically acceptable salt thereof. 8. The method of claim 1, wherein the therapeutically effective amount of atrasentan, or a pharmaceutically acceptable salt thereof, is a once daily dose of about 0.75 mg of atrasentan, or an equivalent amount of a pharmaceutically acceptable salt thereof. 9. The method of claim 1, wherein atrasentan is administered as a pharmaceutically acceptable salt. 10. The method of claim 1, wherein atrasentan is administered as atrasentan hydrochloride. 11. The method of claim 1, wherein the subject has been determined to have proteinuria of at least 0.5 g/day prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 12. The method of claim 1, wherein the subject has been determined to have proteinuria of from about 0.3 g/day to about 2.0 g/day prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 13. The method of claim 1, wherein the subject has been determined to have proteinuria of from about 0.75 g/day to about 1.5 g/day prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 14. The method of claim 1, wherein the subject has an eGFR of from about 30 to about 90 mL/min/1.73 m2 prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 15. The method of claim 2, wherein the subject has an eGFR of at least about 30 mL/min/1.73 m2 prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 16. The method of claim 1, wherein the subject has a UPCR value of greater than or equal to 1 g/g prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 17. The method of claim 2, wherein the subject was determined to have the proteinuria in at least two of three consecutive readings of proteinuria. 18. The method of claim 1, wherein the proteinuria is reduced at about 15 days to about 30 days after administration of an effective amount of atrasentan, or a pharmaceutically acceptable salt thereof. 19. The method of claim 11, wherein the proteinuria was present for at least about 3 months prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 20. The method of claim 12, wherein the proteinuria was present for at least about 3 months prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 21. The method of claim 13, wherein the proteinuria was present for at least about 3 months prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 22. The method of claim 14, wherein the eGFR was present for at least about 3 months prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 23. The method of claim 15, wherein the eGFR was present for at least about 3 months prior to the first administration of atrasentan, or a pharmaceutically acceptable salt thereof. 24. The method of claim 8, wherein the subject's proteinuria is reduced by at least about 10% after treatment with atrasentan, or a pharmaceutically acceptable salt thereof relative to the proteinuria prior to initiation of administration of atrasentan or a pharmaceutically acceptable salt thereof. 25. The method of claim 8, wherein the subject's proteinuria is reduced by at least about 20% after treatment with atrasentan, or a pharmaceutically acceptable salt thereof relative to the proteinuria prior to initiation of administration of atrasentan or a pharmaceutically acceptable salt thereof. 26. The method of claim 8, wherein the subject's proteinuria is reduced by at least about 30% after treatment with atrasentan, or a pharmaceutically acceptable salt thereof relative to the proteinuria prior to initiation of administration of atrasentan or a pharmaceutically acceptable salt thereof. 27. The method of claim 8, wherein the subject's proteinuria is reduced by at least about 10% after treatment for at least 12 weeks or at least 36 weeks with atrasentan, or a pharmaceutically acceptable salt thereof relative to the proteinuria prior to initiation of administration of atrasentan or a pharmaceutically acceptable salt thereof. 28. The method of claim 8, wherein the subject's proteinuria is reduced by at least about 20% after treatment for at least 12 weeks or at least 36 weeks with atrasentan, or a pharmaceutically acceptable salt thereof relative to the proteinuria prior to initiation of administration of atrasentan or a pharmaceutically acceptable salt thereof. 29. The method of claim 8, wherein the subject's proteinuria is reduced by at least about 30% after treatment for at least 12 weeks or at least 36 weeks with atrasentan, or a pharmaceutically acceptable salt thereof relative to the proteinuria prior to initiation of administration of atrasentan or a pharmaceutically acceptable salt thereof. 30. The method of claim 8, wherein the subject has been determined to have proteinuria of at least 1 g/day or of at least 1.5 g/day prior to initiation of administration of atrasentan, or a pharmaceutically acceptable salt thereof. 31. A method of causing a reduction in proteinuria in a subject in need thereof, comprising administering to the subject atrasentan at a once-daily dose of 0.75 mg, or an equivalent amount of a pharmaceutically acceptable salt thereof, wherein the subject has been previously diagnosed with IgA nephropathy and wherein the diagnosis of IgA nephropathy comprises a kidney biopsy, detecting anti-glycan antibodies, detecting deposition of IgA-immune complexes in the kidney, or a combination of any of the foregoing, wherein the subject has proteinuria of less than 1 g/day in at least two of three consecutive readings after initiation of administration of atrasentan, or a pharmaceutically acceptable salt thereof, and wherein the IgA nephropathy is primary IgA nephropathy. 32. The method of claim 31, wherein the subject's proteinuria is reduced by at least about 10% after treatment for at least 12 weeks or at least 36 weeks with atrasentan, or a pharmaceutically acceptable salt thereof, relative to the proteinuria prior to initiation of administration of atrasentan, or a pharmaceutically acceptable salt thereof. 33. The method of claim 31, wherein the subject's proteinuria is reduced by at least about 20% after treatment for at least 12 weeks or at least 36 weeks with atrasentan, or a pharmaceutically acceptable salt thereof, relative to the proteinuria prior to initiation of administration of atrasentan, or a pharmaceutically acceptable salt thereof. 34. The method of claim 31, wherein the subject's proteinuria is reduced by at least about 30% after treatment for at least 12 weeks or at least 36 weeks with atrasentan, or a pharmaceutically acceptable salt thereof, relative to the proteinuria prior to initiation of administration of atrasentan, or a pharmaceutically acceptable salt thereof. 35. The method of claim 31, wherein atrasentan is administered as atrasentan hydrochloride. 36. The method of claim 31, wherein the subject has been determined to have proteinuria of at least 1 g/day or of at least 1.5 g/day prior to initiation of administration of atrasentan, or a pharmaceutically acceptable salt thereof.