METHODS OF TREATMENT WITH MIXED METAL COMPOUND
A method treating and/or preventing vascular calcification can include administering a mixed metal compound to a subject in need thereof.
1 . A method of preventing and/or reducing vascular calcification, comprising:
administering to a subject in need thereof an effective amount of a mixed metal compound of formula (I):
M II 1-x .M III x (OH) 2 A n− y .z H 2 O, (I),
wherein M II is at least one bivalent metal, M III is at least one trivalent metal, A n− is at least one n-valent anion, x=Σny, 0<x≤0.67, 0<y≤1, and 0≤z≤10.
2 . A method of preventing and/or reducing vascular calcification, comprising:
administering to a subject in need thereof an effective amount of a mixed metal compound of formula (II):
M II 1-a M III a O b A n− c .z H 2 O (II),
wherein M II is at least one bivalent metal; M III is at least one trivalent metal; A n− is at least one n-valent anion, 0<x≤0.67, 0<y≤1, and 0≤z≤10.
3 . A method of preventing and/or reducing vascular calcification, comprising:
administering to a subject in need thereof an effective amount of a mixed metal compound of formula (VI):
M II 1-a M III a O b (A n− ) c .z H 2 O (VI)
wherein M II is at least one bivalent metal; M III is at least one trivalent metal; and 1>a>0.4; 0<b≤2; 0<z≤5; A n− is at least one n-valent anion; and 2+a−2b−cn=0.
4 . A method of preventing and/or reducing vascular calcification, comprising:
administering to a subject in need thereof an effective amount of a mixed metal compound of formula (VII)
M II 1-a M III a (OH) d ](A n− ) c .z H 2 O (VII)
wherein M II is at least one bivalent metal; M III is at least one trivalent metal; and 1>a>0.4; A n− is at least one n-valent anion; 2+a−d−cn=0; Σcn<0.9a, 0≤d<2, and 0<z≤5.
5 . The method of claim 1 , wherein M II comprises Mg.
6 . The method of claim 1 , wherein M II is Mg.
7 . The method of claim 1 , wherein M III comprises iron.
8 . The method of claim 1 , wherein A n− comprises carbonate.
9 . The method of claim 1 , wherein M II comprises magnesium, M III comprises iron, and A n− comprises carbonate.
10 . The method of claim 1 , wherein the mixed metal compound is substantially free of calcium.
11 . The method of claim 1 , wherein the subject in need thereof has hyperphosphatemia.
12 . The method of claim 1 , wherein the subject in need thereof has elevated FGF 23.
13 . The method of claim 1 , wherein the subject in need thereof has hyperphosphaturia.
14 . The method of claim 1 , wherein the subject in need thereof has recurrent urolithiasis.
15 . The method of claim 1 , wherein the subject in need thereof has idiopathic hypercalciuria.
16 . The method of claim 1 , wherein the subject in need thereof has hyperparathyroidism.
17 . The method of claim 1 , wherein the subject in need thereof has chronic kidney disease.
18 . The method of claim 16 , wherein the subject in need thereof has Chronic Kidney Disease Stage 3-5.
19 . The method of claim 17 , wherein the subject in need thereof has Chronic Kidney Disease Stage 3-4.
20 . The method of claim 17 , wherein the subject in need thereof has Chronic Kidney Disease Stage 5.
21 . The method of claim 17 , wherein the subject in need thereof has hyperparathyroidism secondary to Chromic Kidney Disease.
22 . The method of claim 11 , wherein the subject in need thereof does not have chronic kidney disease.
23 . The method of claim 1 , wherein the subject is human.
24 . The method of claim 1 , wherein upon administration the mixed metal compound releases the at least one bivalent metal and the at least one bivalent metal is preferentially absorbed by vascular tissue.
25 . The method of claim 24 , wherein the at least one bivalent metal is Mg.
26 . The method of claim 25 , comprising increasing the magnesium to phosphate accumulation in vascular tissue as compared to a control subject not receiving the mixed metal compound.
27 . The method of claim 1 , comprising administering at least about 200 mg of the mixed metal compound.
28 . The method of claim 1 , wherein the mixed metal compound is Mg4Fe2(OH)12CO3.nH2O, wherein n is 2 to 8.
29 . The method of claim 1 , wherein parathyroid hormone is reduced by at least 16%.
30 . The method of claim 1 , wherein a degree of vascular calcification is reduced to less than 40% vascular tissue calcified in the subject as compared to a control subject not receiving the mixed metal compound.
31 . The method of claim 1 , wherein vascular calcification is prevented in the subjects arterial tissue or heart tissue.
32 .- 62 . (canceled)