Ambrisentan for use in the treatment of acute renal failure
Inventors
NAVARRO, Iker • Khanna, Satish
Assignees
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Publication Number
US-10870021-B2
Publication Date
2020-12-22
Expiration Date
Abstract
Ambrisentan and formulations thereof for use in the treatment and prevention of acute renal failure associated with renal vasoconstriction.
Core Innovation
The invention relates to treating and preventing acute renal failure/acute kidney injury associated with renal vasoconstriction mediated by endothelin receptor type A (ETR-A). It provides methods of administering an effective amount of ambrisentan to a subject suffering from conditions associated with renal vasoconstriction, while maintaining plasma levels of ambrisentan below about 100 ng/ml.
The methods are further defined by maintaining ambrisentan plasma levels below about 50 ng/ml and below about 20 ng/ml, to treat the subject. In addition, the invention includes identifying reduced renal function due to vasoconstriction by determining renal function before and after administering ambrisentan.
For subjects awaiting a liver transplant, the invention includes identifying reduced renal function due to vasoconstriction and, if there is an absence of improvement of renal function, making the subject eligible for a dual liver-kidney transplant. In this context, the invention further includes determining reduced renal function due to vasoconstriction tied to subsequent transplantation decisions.
Claims Coverage
The provided claim set includes six independent claims. Across these independent claims, the coverage centers on administering an effective amount of ambrisentan to maintain plasma levels below about 100 ng/ml, with dependent refinements below about 50 ng/ml and/or below about 20 ng/ml, and on determining renal function before and after treatment to identify reduced renal function due to vasoconstriction, including transplant eligibility decisions.
Plasma-limited ambrisentan for hepatorenal syndrome treatment
Administering an effective amount of ambrisentan to a subject suffering from Hepatorenal Syndrome such that plasma levels of ambrisentan are maintained below about 100 ng/ml to treat the subject suffering from Hepatorenal Syndrome.
Plasma-limited ambrisentan for refractory ascites treatment
Administering an effective amount of ambrisentan to a subject suffering from Refractory Ascites such that plasma levels of ambrisentan are maintained below about 100 ng/ml to treat the subject suffering from Refractory Ascites.
Plasma-limited ambrisentan for dilutional hyponatremia treatment
Administering an effective amount of ambrisentan to a subject suffering from Dilutional Hyponatremia such that plasma levels of ambrisentan are maintained below about 100 ng/ml to treat the subject suffering from Dilutional Hyponatremia.
ETR-A linked ambrisentan exposure with renal-function identification in hepatorenal disorder
Administering an effective amount of ambrisentan to a subject suffering from a Hepatorenal Disorder and identifying reduced renal function due to vasoconstriction, wherein renal function is determined before and after administering, and wherein ambrisentan is administered such that plasma levels of ambrisentan are maintained below about 100 ng/ml.
Renal-function identification in liver-transplant candidates using plasma-limited ambrisentan
Administering an effective amount of ambrisentan to a subject awaiting a liver transplant and identifying reduced renal function due to vasoconstriction, wherein renal function is determined before and after treatment, and wherein ambrisentan is administered such that plasma levels of ambrisentan are maintained below about 100 ng/ml.
Dual liver-kidney transplant eligibility based on lack of renal-function improvement with plasma-limited ambrisentan
Administering an effective amount of ambrisentan to a subject awaiting a liver transplant and identifying reduced renal function due to vasoconstriction, wherein renal function is determined before and after treatment, and in the absence of an improvement of renal function in the subject the subject is eligible for a dual liver-kidney transplant, and wherein ambrisentan is administered such that plasma levels of ambrisentan are maintained below about 100 ng/ml.
Across the independent claims, the core claim coverage is treatment of vasoconstriction-associated conditions using ambrisentan with plasma levels maintained below about 100 ng/ml, identification of reduced renal function due to vasoconstriction by determining renal function before and after dosing, and, for liver-transplant candidates, use of the renal function outcomes to determine eligibility for dual liver-kidney transplant when renal function does not improve.
Stated Advantages
Treating Hepatorenal Syndrome
Treating Refractory Ascites
Treating Dilutional Hyponatremia
Identifying reduced renal function due to vasoconstriction
Documented Applications
Treatment of a subject suffering from Hepatorenal Syndrome
Treatment of a subject suffering from Refractory Ascites
Treatment of a subject suffering from Dilutional Hyponatremia
Treating a subject suffering from a Hepatorenal Disorder and identifying reduced renal function due to vasoconstriction
Treating a subject awaiting a liver transplant and identifying reduced renal function due to vasoconstriction
Making a subject awaiting a liver transplant eligible for a dual liver-kidney transplant when there is an absence of improvement of renal function
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