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Claims for Patent: 9,408,858

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Claims for Patent: 9,408,858

Title:Method for treating secondary hyperparathyroidism in CKD
Abstract: A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Inventor(s): Bishop; Charles W. (Miami Beach, FL), Tabash; Samir P. (Whitby, CA), Agudoawu; Sammy A. (Mississauga, CA), White; Jay A. (Newmarket, CA), Crawford; Keith H. (Highlands Ranch, CO), Messner; Eric J. (Lake Forest, IL), Petkovich; P. Martin (Kingston, CA)
Assignee: OPKO RENAL, LLC (Miami, FL) OPKO IRELAND GLOBAL HOLDINGS, LTD. (Grand Cayman, KY)
Application Number:14/690,131
Patent Claims: 1. A method of treating secondary hyperparathyroidism in a human patient having Chronic Kidney Disease (CKD), comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level.

2. The method of claim 1, wherein the patient has CKD Stage 5.

3. The method of claim 1, wherein the patient has CKD Stage 1 or 2.

4. The method of claim 1, wherein the patient has CKD Stage 3 or 4.

5. The method of claim 1, wherein the patient's plasma intact parathyroid hormone level is reduced to the target range for the CKD Stage.

6. The method of claim 1, wherein the patient's plasma intact parathyroid hormone level is reduced by at least 30% compared to the pre-treatment level.

7. The method of claim 1, wherein the patient is vitamin D insufficient or vitamin D deficient.

8. The method of claim 7, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to increase the patient's serum total 25-hydroxyvitamin D level to at least about 30 ng/mL.

9. The method of claim 1, wherein the patient is vitamin D replete.

10. The method of claim 1, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to maintain the patient's serum total 25-hydroxyvitamin D at a level of about 30 ng/mL or above.

11. The method of claim 1, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to raise and maintain the patient's serum 25-dihydroxyvitamin D at a level between about 50 ng/mL and about 90 ng/mL.

12. The method of claim 1, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D is also effective to raise and maintain the patient's blood 1,25-dihydroxyvitamin D at a level of at least about 30 pg/mL.

13. The method of claim 1, wherein the 25-hydroxyvitamin D is selected from the group consisting of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, and a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.

14. The method of claim 13, wherein the 25-hydroxyvitamin D is 25-hydroxyvitamin D.sub.3.

15. The method of claim 1, comprising administering said oral dosage on a schedule of once per day.

16. The method of claim 15, comprising administering said oral dosage daily for at least one month.

17. The method of claim 15, wherein the daily dose of 25-hydroxyvitamin D is in a range of 1 .mu.g to 1000 .mu.g.

18. The method of claim 15, wherein the daily dose of 25-hydroxyvitamin D is in a range of 1 .mu.g to 100 .mu.g.

19. The method of claim 1, wherein said effective amount of the controlled release, oral dosage form of 25-hydroxyvitamin D does not cause hypercalciuria.

20. The method of claim 1, wherein said controlled release, oral dosage form of 25-hydroxyvitamin D comprises 25-hydroxyvitamin D.sub.3 in a range of 1 .mu.g to 100 .mu.g, a waxy controlled release carrier agent, a lipoidic agent, and an oily vehicle for the 25-hydroxyvitamin D.sub.3.

21. A method of treating secondary hyperparathyroidism in a human patient having Chronic Kidney Disease (CKD), comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level without causing hypercalcemia or hyperphosphatemia.

22. A method of treating secondary hyperparathyroidism in a human patient having Chronic Kidney Disease (CKD), comprising administering to the patient an effective amount of a controlled release, oral dosage form of 25-hydroxyvitamin D to reduce the patient's serum parathyroid hormone level by at least 30% while safely raising serum total 25-hydroxyvitamin D.
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