Treating chronic uremic patients undergoing periodic dialysis

• US 6,696,493 B2
• Filed: 07/08/2002
• Issued: 02/24/2004
• Est. Priority Date: 01/19/2000
• Status: Expired due to Term

• Current Assignee: Alfasigma S.p.A.
• Original Assignee: Sigma-Tau Industrie Farmaceutiche Riunite SPA (Alfasigma S.p.A.)
• Inventors: Cavazza, Claudio
• Primary Examiner(s): Reamer, James H
• Application Number:
  US10/189,451
• Publication Number:
  US 20020198263A1
• Time in Patent Office: 596 Days
• Field of Search: 514/561
• US Class Current: 514/561
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 31/205 Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 47/6425 the peptide or protein in the drug conjugate being a receptor, e.g. CD4, a cell surface antigen, i.e. not a peptide ligand targeting the antigen, or a cell surface determinant, i.e. a part of the surface of a cell
• CPC Class Codes: C07K 14/705 Receptors; Cell surface antigens; Cell surface determinants tumour specific antigens C07K14/4748
• CPC Class Codes: C07K 16/28 against receptors, cell surface antigens or cell surface determinants
• CPC Class Codes: C07K 16/30 from tumour cells

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.

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 μ

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 μ

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 μ

M.

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

M.