IP Library Granted Patent US 11,173,168
Granted Patent B2
US 11,173,168 · App. 16/089,235 · Granted Nov 16, 2021

Methods of treating vitamin D insufficiency in chronic kidney disease

Inventors: Joel Z. Melnick (Evanston, IL); Charles W. Bishop (Miami Beach, FL); P. Martin Petkovich (Kingston, CA); Stephen A. Strugnell (Bay Harbor Islands, FL)
Assignee: EIRGEN PHARMA LTD.
A61K31/593A61K9/0053A61K31/592A61P3/02A61P13/12
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Quick Facts
Patent No.
US 11,173,168
App. No.
16/089,235
Granted
Nov 16, 2021
Kind
B2
Abstract

Methods for treating vitamin D insufficiency and secondary hyperparathyroidism in patients having CKD comprising administering repeat doses of 25-hydroxyvitamin D are disclosed. The methods comprise administering 25-hydroxyvitamin D in an amount effective to safely raise the patient's serum 25-hydroxyvitamin D level to greater than 90 ng/ml and/or to control the patient's serum ratio of 25-hydroxyvitamin D to 24,25-dihydroxyvitamin D to less than 20.

Claims (14)

1. A method of treating secondary hyperparathyroidism in a patient having Chronic Kidney Disease Stage 3 or 4, comprising selecting a patient having Chronic Kidney Disease Stage 3 or 4 and a serum ratio of serum 25-hydroxyvitamin D to serum 24,25-dihydroxyvitamin D of greater than 20 and a serum 25-hydroxyvitamin D level of at least 30 ng/mL, and administering to the patient repeat doses of 25-hydroxyvitamin D effective to (a) raise the patient's serum 25-hydroxyvitamin D level to greater than 90 ng/ml and (b) control the patient's serum ratio of serum 25-hydroxyvitamin D to serum 24,25-dihydroxyvitamin D to less than 20.

2. The method of claim 1 , comprising administering the repeat doses for at least 3 months.

3. The method of claim 1 , wherein the repeat doses are effective to raise the patient's serum 25-hydroxyvitamin D level to greater than 100 ng/ml.

4. The method of claim 1 wherein the repeat doses are administered at a frequency of one dose per day.

5. The method of claim 2 , comprising administering the repeat doses at least six months.

6. The method of claim 1 , comprising raising the patient's serum 25-hydroxyvitamin D level to greater than about 110 ng/mL, optionally, without any adverse reactions.

7. The method of claim 6 , comprising raising the patient's serum 25-hydroxyvitamin D level to greater than about 110 ng/mL without causing one or more of hypercalcemia, hyperphosphatemia, hypercalciuria, and adynamic bone disease.

8. The method of claim 1 , wherein the patient is not receiving Vitamin D hormone replacement therapy.

9. The method of claim 3 , wherein the repeat doses are effective to raise the patient's serum 25-hydroxyvitamin D level to greater than 125 ng/mL.

10. The method of claim 9 , wherein the repeat doses are effective to raise the patient's serum 25-hydroxyvitamin D level to greater than 150 ng/mL.

11. The method of claim 10 , wherein the repeat doses are effective to raise the patient's serum 25-hydroxyvitamin D level to greater than 200 ng/mL.

12. The method of claim 1 , comprising administering to the patient repeat doses of 25-hydroxyvitamin D effective to control the patient's serum ratio of serum 25-hydroxyvitam D to serum 24,25-dihydroxyvitamin D to less than 19, less than 18, less than 17, or less than 16.

13. The method of claim 12 , comprising administering to the patient repeat doses of 25-hydroxyvitamin D effective to control the patient's serum ratio of serum 25-hydroxyvitam D to serum 24,25-dihydroxyvitamin D to less than 15, less than 14, less than 13, less than 12, less than 11, or less than 10.

14. The method of claim 1 , wherein the repeat doses of 25-hydroxyvitamin D are, or average, greater than 90 μg per day.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2021
From: OPKO IRELAND GLOBAL HOLDINGS, LTD.
To: EIRGEN PHARMA LTD.
Reel/Frame 055765/0953 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2018
From: MELNICK, JOEL Z.; BISHOP, CHARLES W.; PETKOVICH, P. MARTIN; STRUGNELL, STEPHEN A.
To: OPKO IRELAND GLOBAL HOLDINGS, LIMITED
Reel/Frame 047768/0543 →
Continuity (2)
Provisional Application 62314359 · Mar 28, 2016
Related Publication 20190083513A1 · Mar 21, 2019
Cited By (1)
US 12,208,106