Use of amides of mono- and dicarboxylic acids in the treatment of renal diseases

Abstract

A therapy for renal diseases, in particular renal diseases which develop in diabetic patients or patients who have been subjected to a treatment with an antitumor chemotherapy such as a platinum derivative and more generally cytotoxic drugs at renal level for treating of neoplastic diseases. More particularly, the present invention relates to palmitoylethanolamide and diethanolamide of fumaric acid for use in the treatment of renal diseases, in particular those caused by dysmetabolic diseases or by toxic or chemotherapy agents, such as platinum derivatives. Palmitoylethanolamide is used preferably in micronized or ultra-micronized form. Diethanolamide of fumaric acid is used preferably in aqueous solution.

1 . Mono- or diamide of a C12-C20 monocarboxylic acid, saturated or monounsaturated, or of a C4-C14 dicarboxylic acid, saturated or monounsaturated, respectively, with an amine selected from among monoethanolamine and serine, or mixtures of said mono- or diamides, for use in the treatment of renal diseases. 
     
     
         2 . Monoamide of monocarboxylic acid according to  claim 1 , wherein said monocarboxylic acid, saturated or monounsaturated, is selected from among palmitic acid, stearic acid and oleic acid. 
     
     
         3 . Diamide of dicarboxylic acid according to  claim 1 , wherein said dicarboxylic acid, saturated or monounsaturated, is selected from among fumaric acid, azelaic acid and traumatic acid. 
     
     
         4 . Mono- or diamide according to  claim 1 , wherein said mono- or diamide is palmitoylethanolamide or diethanolamide of fumaric acid. 
     
     
         5 . Mono-amide according to  claim 4 , wherein said palmitoylethanolamide is in micronized form. 
     
     
         6 . Mono-amide according to  claim 2 , wherein at least 940 or at least 950 or about 96% of the particles of said micronized palmitoylethanolamide has a dimension smaller than 10 microns and preferably at least 77% or at least 78% or about 80% of the particles of said micronized palmitoylethanolamide has a dimension smaller than 6 microns. 
     
     
         7 . Mono-amide according to  claim 4 , wherein said palmitoylethanolamide is totally or partly in ultra micronized form. 
     
     
         8 . Mono-amide according to  claim 7 , wherein at least 97% or at least 98% or at least 99% or about 99.9% of the particles of said ultra-micronized palmitoylethanolamide has dimensions smaller than 6 microns and preferably at least 57% or at least 58% or at least 59% or about 59.6% of the particles of said ultra-micronized palmitoylethanolamide has dimensions smaller than 2 microns. 
     
     
         9 . Method of treating renal diseases caused by dysmetabolic diseases or by toxic agents, comprising administering a therapeutically effective amount of a mono- or diamide according to  claim 1  to a patient in need thereof. 
     
     
         10 . The method according to  claim 9 , wherein said renal diseases are selected from among:
 Diabetic nephropathy   Nephroangiosclerosis   Pyelonephrite   Polycystic renal disease (polycystic kidney)   Alport syndrome   Lesch-Nyham syndrome   Goodpasture's syndrome   Lupus nephritis   Immunoglobulin A nephropathy   Tubular necrosis   Glomerulonephritis   Urethral stenosis   Iatrogenous nephropathies (from NSAIDs, from cytotoxic drugs, from Lithium, from antibiotics, from Cyclosporine, etc)   Nephropathies from therapeutic radiations   Nephropathies of the aged.   
     
     
         11 . The method according to  claim 9 , wherein said method of treating is oral. 
     
     
         12 . Mono- or diamide according to  claim 1 , wherein said mono- or diamide is contained in a pharmaceutical composition at an amount ranging between 1 mg and 2 g, or between 100 mg and 1 g of the active ingredient per dosage unit. 
     
     
         13 . Mono- or diamide according to  claim 1 , wherein said mono- or diamide is contained in a pharmaceutical composition selected from among tablets, capsules, solutions, syrups, suspensions, possibly of the controlled release type, for oral administration; tablets by buccal or sublingual administration; suspensions, solutions or emulsions in oily or aqueous carriers for injectable administration; suppositories or retention enema for rectal administration; deposit preparations for subcutaneous, transcutaneous or intramuscular administration or for intramuscular injection. 
     
     
         14 . Diamide according to  claim 1 , wherein said diamide is diethanolamide of fumaric acid in injectable form. 
     
     
         15 . The method according to  claim 9 , for human treatments. 
     
     
         16 . The method according to  claim 9 , for veterinary treatment.