Claims for Patent: 11,801,253

Summary for Patent: 11,801,253

Title:	Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease
Abstract:	A method of treating and preventing secondary hyperparathyroidism in CKD by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering 25-hydroxyvitamin D3 with or without 25-hydroxyvitamin D2 and, as necessary, 1,25-dihydroxyvitamin D2 as a Vitamin D hormone replacement therapy.
Inventor(s):	Charles W. Bishop, Eric J. Messner
Assignee:	Opko Health Inc , Opko Renal LLC
Application Number:	US15/720,830
Patent Claims:	1. A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease, comprising administering a sustained release composition comprising 25-hydroxyvitamin D3 and optionally D2 to increase or maintain blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the patient, wherein 25-hydroxyvitamin D3 is the predominant prohormone in circulation, wherein the patient is receiving one or more medications that increase the catabolism of vitamin D, or one or more medications that reduce absorption of vitamin D, or one or more medications that inhibit activation of vitamin D, or one or more medications that decrease calcium absorption, or any combination of the foregoing. 2. The method of claim 1, wherein the patient is receiving phenytoin, or fosphenytoin, or phenobarbital, or carbamazepine, or rifampin. 3. The method of claim 2, wherein the patient is receiving phenytoin. 4. The method of claim 2, wherein the patient is receiving fosphenytoin. 5. The method of claim 2, wherein the patient is receiving phenobarbital. 6. The method of claim 2, wherein the patient is receiving carbamazepine. 7. The method of claim 2, wherein the patient is receiving rifampin. 8. The method of claim 1, wherein the patient is receiving cholestyramine, or colestipol, or orlistat, or a fat substitute. 9. The method of claim 8, wherein the patient is receiving cholestyramine. 10. The method of claim 9, wherein the patient suffers from obesity. 11. The method of claim 10, wherein the patient has CKD Stage 3 or 4. 12. The method of claim 8, wherein the patient is receiving colestipol. 13. The method of claim 8, wherein the patient is receiving orlistat. 14. The method of claim 8, wherein the patient is receiving a fat substitute. 15. The method of claim 8, wherein the patient suffers from obesity. 16. The method of claim 1, wherein the patient is receiving one or more medications that inhibit activation of vitamin D. 17. The method of claim 16, wherein the patient is receiving ketoconazole. 18. The method of claim 1, wherein the patient is receiving one or more medications that decrease calcium absorption. 19. The method of claim 18, wherein the patient is receiving a corticosteroid. 20. The method of claim 1, wherein the patient suffers from obesity. 21. The method of claim 1, wherein the sustained release composition comprising 25-hydroxyvitamin D3 and optionally D2 comprises a soft gelatin capsule. 22. The method of claim 1, wherein the patient is receiving one or more medications that increase the catabolism of vitamin D. 23. The method of claim 1, wherein the patient is receiving one or more medications that reduce absorption of vitamin D. 24. A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease, comprising administering a sustained release composition comprising 25-hydroxyvitamin D3 and optionally 25-hydroxyvitamin D2 to increase or maintain blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the patient, wherein 25-hydroxyvitamin D3 is the predominant prohormone in circulation, in a patient receiving a medication that increases the catabolism of vitamin D, or a medication that reduce absorption of vitamin D, or a medication that inhibits activation of vitamin D, or a medication that decreases calcium absorption. 25. The method of claim 24, wherein the patient is receiving phenytoin, fosphenytoin, phenobarbital, carbamazepine, rifampin, cholestyramine, colestipol, orlistat, ketoconazole, or a corticosteroid. 26. The method of claim 25, wherein the sustained release composition comprising 25-hydroxyvitamin D3 and optionally 25-hydroxyvitamin D2 comprises a soft gelatin capsule.