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Last Updated: March 28, 2024

Claims for Patent: 9,402,855


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Summary for Patent: 9,402,855
Title:Method of treating and preventing secondary hyperparathyroidism
Abstract: The method of treating elevated blood levels of iPTH by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering, as necessary, both Vitamin D repletion and Vitamin D hormone replacement therapies, is disclosed. The blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patient\'s normal historical physiological range for 1,25-dihydroxyvitamin D without causing substantially increased risk of hypercalcemia, hyperphosphatemia or over suppression of plasma iPTH in the patient. The blood levels of 25-hydroxyvitamin D are maintained at or above 30 ng/mL between doses of Vitamin D repletion therapies, and the blood levels of 1,25-dihydroxyvitamin D are maintained in the patient\'s normal historical physiological range between doses of Vitamin D hormone replacement therapies. In one aspect, the disclosure includes methods wherein the blood concentration of 25-hydroxyvitamin D during treatment comprises predominantly 25-hydroxyvitamin D.sub.3, and/or wherein the method includes administering predominantly or solely 25-hydroxyvitamin D.sub.3 for 25-hydroxyvitamin D repletion and/or maintenance.
Inventor(s): Bishop; Charles W. (Mount Horeb, WI), Crawford; Keith H. (Highlands Ranch, CO), Messner; Eric J. (Lake Forest, IL), Petkovich; P. Martin (Kingston, CA), Helvig; Christian F. (Markham, CA)
Assignee: OPKO RENAL, LLC (Miami, FL) OPKO IRELAND GLOBAL HOLDINGS, LTD. (Grand Cayman, KY)
Application Number:13/680,997
Patent Claims:1. A method of treating or preventing secondary hyperparathyroidism in Chronic Kidney Disease (CKD) Stage 3 or Stage 4 in a human patient, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies.

2. The method of claim 1, wherein the Vitamin D repletion therapy comprises administering to the patient a compound for Vitamin D repletion selected from the group consisting of ergocalciferol, cholecalciferol, 25-hydroxyvitamin D.sub.3, 25-hydroxyvitamin D.sub.2, and combinations thereof.

3. The method of claim 2, wherein the repletion therapy comprises administering to the patient a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.

4. The method of claim 2, wherein the compound for Vitamin D repletion is 25-hydroxyvitamin D.sub.3.

5. The method of claim 2, wherein the repletion therapy comprises administering to the patient a combination of ergocalciferol and cholecalciferol.

6. The method of claim 1, wherein the Vitamin D hormone replacement therapy comprises administering to the patient a compound for Vitamin D hormone replacement selected from the group consisting of 1,25-dihydroxyvitamin D.sub.2, 1,25-dihydroxyvitamin D.sub.3, 1,25-dihydroxyvitamin D.sub.4, 1.alpha.-hydroxyvitamin D.sub.2, 1.alpha.hydroxyvitamin D.sub.3, and combinations thereof.

7. The method of claim 6, wherein the compound for Vitamin D hormone replacement is 1,25-dihydroxyvitamin D.sub.2.

8. The method of claim 1, wherein the Vitamin D repletion therapy and/or the Vitamin D hormone replacement therapy comprises controllably releasing a compound for Vitamin D repletion and/or Vitamin D hormone replacement.

9. The method of claim 8, wherein the Vitamin D repletion therapy comprises controllably releasing a compound for Vitamin D repletion.

10. The method of claim 8, wherein the Vitamin D hormone replacement therapy comprises controllably releasing a compound for Vitamin D hormone replacement.

11. The method of claim 8, wherein controllably releasing a compound comprises reducing the maximum serum concentration of the compound in a dose interval (Cmax) compared to an equivalent amount of the compound administered by bolus IV injection and/or an equivalent immediate-release, oral dosage form.

12. The method of claim 8, wherein controllably releasing a compound comprises increasing the time for the plasma concentration of the compound to reach its maximum in a dose interval following administration (Tmax) compared to an equivalent amount of the compound administered by bolus IV injection and/or an equivalent immediate-release, oral dosage form.

13. The method of claim 8, wherein controllably releasing a compound comprises decreasing the ratio of the maximum serum concentration within 24 hours after administration of the compound to the concentration 24 hours after administration (Cmax.sub.24hr/C.sub.24hr) compared to an equivalent amount of the compound administered by bolus IV injection and/or an immediate-release, oral dosage form.

14. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies to lower the patient's serum parathyroid level by at least 30%.

15. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies to lower the patient's serum parathyroid level to the target range for the CKD stage.

16. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies such that oversuppression of the patient's serum parathyroid hormone is avoided.

17. The method of claim 1, where the patient does not have renal osteodystrophy.

18. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies to increase or maintain the patient's blood level of 25-hydroxyvitamin D to at least 30 ng/mL.

19. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies to increase or maintain the patient's blood level of 1,25-dihydroxyvitamin D to at least 25 pg/mL.

20. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies such that the patient's blood level of 25-hydroxyvitamin D comprises predominantly 25-hydroxyvitamin D.sub.3.

21. The method of claim 1, comprising administering to the patient both Vitamin D repletion and Vitamin D hormone replacement therapies to avoid supraphysiologic levels of 25-hydroxyvitamin D.

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