IP Library Granted Patent US 11,801,253
Granted Patent B2
US 11,801,253 · App. 15/720,830 · Granted Oct 31, 2023

Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease

Inventors: Charles W. Bishop (Miami Beach, FL); Eric J. Messner (Lake Forest, IL)
Assignee: OPKO RENAL, LLC
A61K31/593A61K31/59A61K31/592A61K45/06
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Quick Facts
Patent No.
US 11,801,253
App. No.
15/720,830
Granted
Oct 31, 2023
Kind
B2
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 D 3 with or without 25-hydroxyvitamin D 2 and, as necessary, 1,25-dihydroxyvitamin D 2 as a Vitamin D hormone replacement therapy.

Claims (26)

1. A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease, comprising administering a sustained release composition comprising 25-hydroxyvitamin D 3 and optionally D 2 to increase or maintain blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the patient, wherein 25-hydroxyvitamin D 3 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 D 3 and optionally D 2 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 D 3 and optionally 25-hydroxyvitamin D 2 to increase or maintain blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the patient, wherein 25-hydroxyvitamin D 3 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 D 3 and optionally 25-hydroxyvitamin D 2 comprises a soft gelatin capsule.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2019
From: MESSNER, ERIC J.; BISHOP, CHARLES W.
To: PROVENTIV THERAPEUTICS, LLC
Reel/Frame 048394/0122 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2019
From: PROVENTIV THERAPEUTICS, LLC
To: OPKO HEALTH, INC.
Reel/Frame 048394/0143 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2019
From: OPKO HEALTH, INC.
To: OPKO RENAL, LLC
Reel/Frame 048394/0169 →
Continuity (4)
Continuation 14291666 · May 30, 2014
Continuation 12597234
Provisional Application 60913850 · Apr 25, 2007
Related Publication 20180021355A1 · Jan 25, 2018