US2017014471A1PendingUtilityA1

Compositions and methods for treating renal failure

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Assignee: LA JOLLA PHARMA COPriority: Apr 26, 2013Filed: Sep 30, 2016Published: Jan 19, 2017
Est. expiryApr 26, 2033(~6.8 yrs left)· nominal 20-yr term from priority
Inventors:George Tidmarsh
A61P 13/12A61P 1/16A61K 45/06A61K 31/137A61K 31/165A61K 38/095A61K 9/0019A61K 38/085
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Claims

Abstract

The present disclosure relates to the use of angiotensin II in therapeutic methods for the treatment of renal failure, especially renal failure associated with cirrhosis.

Claims

exact text as granted — not AI-modified
1 - 14 . (canceled) 
     
     
         15 . A method of assessing the response of a patient with renal failure associated with cirrhosis to angiotensin therapy, comprising administering to the patient an initial dose of a composition comprising angiotensin II and testing the patient for a change in a therapeutic parameter. 
     
     
         16 . The method of  claim 15 , wherein the therapeutic parameter is serum creatinine level, estimated glomerular filtration rate, serum sodium level, serum potassium level, urine sodium concentration, or blood pressure. 
     
     
         17 . The method of  claim 16 , wherein a decrease in the patient's serum creatinine level, urine sodium concentration, or serum potassium level or an increase in the patient's blood pressure, serum sodium level, or estimated glomerular filtration rate is indicative of a positive response to the angiotensin therapy. 
     
     
         18 . The method of  claim 17 , further comprising, if the patient has a positive response, administering an additional dose of angiotensin II to the patient. 
     
     
         19 . The method of  claim 15 , further comprising, prior to administering the composition to the patient, measuring serum creatinine level and/or 24-hour serum creatinine clearance of the patient; and if a) the measured serum creatinine level is greater than 1.5 mg/dl and/or b) the measured 24-hour serum creatinine clearance is less than 40 ml/min, administering to the patient the composition. 
     
     
         20 . The method of  claim 15 , wherein testing is performed at least half an hour after administering, preferably at least one hour. 
     
     
         21 . The method of  claim 15 , wherein testing is performed less than eight hours after administering, preferably less than 6 hours. 
     
     
         22 . The method of  claim 15 , wherein the initial dose is less than 1 ng/kg/min or about 1 ng/kg/min. 
     
     
         23 . The method of  claim 15 , wherein the angiotensin II is 5-valine angiotensin II acetate, 5-valine angiotensin II amide, 5-L-isoleucine angiotensin II acetate, and 5-L-isoleucine angiotensin II amide, or a pharmaceutically acceptable salt thereof. 
     
     
         24 . The method of  claim 15 , wherein the composition is suitable for parenteral administration. 
     
     
         25 . The method of  claim 24 , wherein the parenteral administration is injection or intravenous infusion. 
     
     
         26 . The method of  claim 15 , wherein the composition further comprises an additional pharmaceutical agent. 
     
     
         27 . The method of  claim 26 , wherein the additional pharmaceutical agent is useful for the treatment of the renal failure associated with cirrhosis. 
     
     
         28 . The method of  claim 26 , wherein the additional pharmaceutical agent is terlipressin, norepinephrine, or midodrine.

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