# US 12,109,254 B2 · Vitamins and alpha keto acid compositions for use in a treatment program for chronic kidney disease patients

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- Number: US 12,109,254 B2
- Document ID: US12109254B2
- Status: Granted
- Kind: B2
- Application number: 17/945,043
- Filed: 2022-09-14
- Published: 2023-01-26
- Granted: 2024-10-08
- Earliest claimed: 2017-11-29
- Assignees: Edgar Hull
- Applicants: Edgar Lee Hull, Jr.
- Inventors: Edgar Lee Hull, Jr.; Narashima Murthy; Sridhara Am
- Web page: https://patentgrep.com/patent/US12109254B2

## CPC

- A61K 38/443: {acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)}
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/4172: Imidazole-alkanecarboxylic acids, e.g. histidine
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
- A61K 31/51: Thiamines, e.g. vitamin B1
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/525: Isoalloxazines, e.g. riboflavins, vitamin B2
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 38/446: {Superoxide dismutase (1.15)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A low nitrogen protein food composition Albutrix™ for use by kidney patients in Stages 3, 4, 4a, 4b, and 5, who are not on dialysis, in a treatment program comprising administering daily a: low nitrogen diet; low nitrogen protein food comprising magnesium and/or calcium salts of alpha keto acids; and time released vitamin. The vitamin comprises the active ingredients of: Zinc; Selenium; Vitamins B1, B2, B6, B12, B5, E, and K2; Niacin; superoxide dismutase; catalase; glutathione and Folate; and excludes calcium, magnesium, phosphorus, sodium, manganese, fluoride, Vitamin D and K1. The low nitrogen food contains daily up to 300 mg of nitrogen; and at least five alpha keto analogues of magnesium and/or calcium salts of: leucine, isoleucine, methionine (MEMS-II), phenylalanine (PAMS-I), and valine. The treatment results in an increase of Glomerular Filtration Rate (GFR), a decrease in blood urea levels, and a decrease in creatinine levels.

## Claims

### Claim 1

A low nitrogen protein food composition for a patient in need thereof comprising as active ingredients at least five alpha keto analogues of amino acids: a) wherein the alpha keto analogues are five magnesium salts comprising:
isoleucine is about 15.0% wt./wt.;
leucine is about 29.0% wt./wt.;
methionine is about 8.33% wt./wt.;
phenylalanine is about 1.31% wt/wt;
valine is about 16.10% wt./wt.; and
b) wherein the low nitrogen protein food composition comprises up to 500 mg daily of nitrogen
c) wherein the patient has Stage 3 kidney disease, is not on dialysis, and experiences a slowdown in the progression of said Stage 3 kidney disease;
d) wherein the patient experiences on average: a 42% reduction in blood urea nitrogen; a 23% reduction in creatinine; a 28% increase in glomerular filtration rate (GFR); and a lower tacrolimus dose for transplant patients.

### Claim 2

A low nitrogen protein food composition for a patient in need thereof comprising as active ingredients amounts of at least five alpha keto analogues of an amino acid: a) wherein the amounts of the alpha keto analogues are:
i) a magnesium salt of leucine at about 28.37% wt./wt., methionine at about 8.18% wt./wt., and valine at about 6.06% wt./wt.;
ii) a calcium salt of isoleucine at about 15.0% wt./wt., phenylalanine at about 1.31% wt./wt., and valine at about 10.09% wt./wt.;
b) wherein the low nitrogen protein food composition comprises up to 500 mg daily of nitrogen
c) wherein the patient has Stage 4 kidney disease, is not on dialysis, and experiences a slowdown in the progression of said Stage 4 kidney disease; and
d) wherein the patient experiences on average: a 42% reduction in blood urea nitrogen; a 23% reduction in creatinine; a 28% increase in glomerular filtration rate (GFR); and a lower tacrolimus dose for transplant patients.

### Claim 3

A low nitrogen protein food composition for a patient in need thereof comprising as active ingredients amounts of at least five alpha keto analogues of an amino acid: a) wherein the amounts of the alpha keto analogues are a calcium salt of: isoleucine at about 14.77% wt./wt., leucine at about 28.67% wt./wt., methionine at about 8.09% wt./wt., phenylalanine at about 1.30% wt./wt., and valine at about 16.00% wt./wt.;
b) wherein the low nitrogen protein food composition comprises up to 500 mg daily of nitrogen
c) wherein the patient has Stage 5 kidney disease, is not on dialysis, and experiences a slowdown in the progression of said Stage 5 kidney disease; and iv) wherein said treatment program slows the progression of incurable chronic kidney disease; and
d) wherein the patient experiences on average: a 42% reduction in blood urea nitrogen; a 23% reduction in creatinine; a 28% increase in glomerular filtration rate (GFR); and a lower tacrolimus dose for transplant patients.

### Claim 4 (depends on 1)

The low nitrogen protein food composition of claim 1, further comprising: histidine amino acid; L-lysine acetate; L-threonine; and tryptophan.

### Claim 5 (depends on 2)

The low nitrogen protein food composition of claim 2, further comprising: histidine amino acid; L-lysine acetate; L-threonine; tryptophan; and tyrosine.

### Claim 6 (depends on 3)

The low nitrogen protein food composition of claim 3, further comprising: histidine amino acid; L-lysine acetate; L-threonine; tryptophan; and tyrosine.

### Claim 7 (depends on 1)

The low nitrogen protein food composition of claim 1, further comprising: the low nitrogen protein diet composition; and/or a time released vitamin composition comprising: as active ingredients: Zinc; Selenium; B1-Thiamine; B2-Riboflavin; Niacin; B6 Pyridoxine; Folic Acid; B12; B5; Vitamin E; Vitamin K2; glutathione (GSH); superoxide dismutase (SOD); and catalase (CAT); and excluding all of the following: calcium (Ca); magnesium (Mg); phosphorus (P); sodium (Na); manganese (Mn); fluoride (F); Vitamin D; and Vitamin K1; and wherein the low nitrogen protein food and vitamin compositions are in a pill formulation.

### Claim 8 (depends on 2)

The low nitrogen protein food composition of claim 2, further comprising: the low nitrogen protein diet composition; and a time released vitamin composition comprising: as active ingredients: Zinc; Selenium; B1-Thiamine; B2-Riboflavin; Niacin; B6 Pyridoxine; Folic Acid; B12; B5; Vitamin E; Vitamin K2; glutathione (GSH); superoxide dismutase (SOD); and catalase (CAT); and excluding all of the following: calcium (Ca); magnesium (Mg); phosphorus (P); sodium (Na); manganese (Mn); fluoride (F); Vitamin D; and Vitamin K1; and wherein the low nitrogen protein food and vitamin compositions are in a pill formulation.

### Claim 9 (depends on 3)

The low nitrogen protein food composition of claim 3, further comprising: the low nitrogen protein diet composition; and/or a time released vitamin composition comprising: as active ingredients: Zinc; Selenium; B1-Thiamine; B2-Riboflavin; Niacin; B6 Pyridoxine; Folic Acid; B12; B5; Vitamin E; Vitamin K2; glutathione (GSH); superoxide dismutase (SOD); and catalase (CAT); and excluding all of the following: calcium (Ca); magnesium (Mg); phosphorus (P); sodium (Na); manganese (Mn); fluoride (F); Vitamin D; and Vitamin K1; and wherein the low nitrogen protein food and vitamin compositions are in a pill formulation.