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Claims for Patent: 6,696,493

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Claims for Patent: 6,696,493

Title: Treating chronic uremic patients undergoing periodic dialysis
Abstract:The method for the treatment of chronic uremic patients undergoing periodical dialysis is useful for preventing and/or treating carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. The method according to the present invention comprises administering an effective dose of carnitine intravenously into the venous return line after each dialysis session.
Inventor(s): Cavazza; Claudio (Rome, IT)
Assignee: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. (Rome, IT)
Application Number:10/189,451
Patent Claims: 1. A method of preventing or treating carnitine deficiency in chronic uremic patients undergoing periodic dialysis comprising administering to a patient at the conclusion of the dialysis into a venous return line after a dialysis session from about 10 to about 20 mg/kg body weight of carnitine, calculated as L-carnitine, or of a pharmaceutically acceptable salt thereof to restore a level of carnitine in the patient to a pre-dialytic level of at least 40 .mu.M, and thereafter reducing the amount of carnitine administered to a level sufficient to maintain carnitine levels to the pre-dialytic level.

2. The method of claim 1, wherein the treatment to achieve pre-dialytic levels is on a weekly basis repeated twice a week every 44 hours, then after 68 hours.

3. The method of claim 2, wherein the treatment is continued for 3-4 weeks.

4. The method of claim 1, wherein the pre-dialytic level of carnitine is at least 50 .mu.M.

5. The method of claim 1, wherein a maintenance dosage of about 5 mg/kg of carnitine is administered.

6. A method of preventing or treating carnitine deficiency in chronic uremic patients undergoing periodic dialysis comprising administering to a patient at the conclusion of the dialysis into a venous return line from about 10 to about 20 mg/kg body weight of carnitine, calculated as L-carnitine, or of a pharmaceutically acceptable salt thereof, wherein the administering of L-carnitine or of a pharmaceutically acceptable salt thereof is prompted by the patient demonstrating an initial pre-dialysis plasma carnitine level equal or lower than 50 .mu.M.

7. The method of claim 6, wherein the initial pre-dialysis concentration is equal or lower than 40 .mu.M.
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