Abstract: In one aspect the present invention is directed to mutant Neutrophil gelatinase-associated lipocalin (NGAL) proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: The subject method described herein relates to a method of treating, preventing, or reducing the incidence of Acute Kidney Injury (AKI) in a subject in need thereof by administering to the subject a pharmaceutically effective amount of one or more amino acids.

Abstract: In one aspect the present invention is directed to mutant Neutrophil gelatinase-associated lipocalin (NGAL) proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: The present invention provides methods for treatment of volume-dependent Acute Kidney Injury (vAKI) and ischemic Acute Kidney Injury (iAKI), as well as methods for diagnosing vAKI and iAKI. The methods are based on determining the levels of PAPPA2, NGAL, KRT20, or TACSTD2 protein in a sample from a patient, such as a urine sample. The present invention also provides a device and a diagnostics kit for determining whether a sample from a subject contains PAPPA2, NGAL, KRT20, or TACSTD2 protein.

Abstract: In one aspect the present invention is directed to mutant NGAL proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: In one aspect the present invention is directed to mutant NGAL proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: In one aspect the present invention is directed to mutant Neutrophil Gelatinase Associated Lipocalin (NGAL) proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: The present invention provides methods for treatment of volume-dependent Acute Kidney Injury (vAKI) and ischemic Acute Kidney Injury (iAKI), as well as methods for diagnosing vAKI and iAKI. The methods are based on determining the levels of PAPPA2, NGAL, KRT20, or TAC-STD2 protein in a sample from a patient, such as a urine sample. The present invention also provides a device and a diagnostics kit for determining whether a sample from a subject contains PAPPA2, NGAL, KRT20, or TACSTD2 protein.

Abstract: In one aspect the present invention is directed to mutant NGAL proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: In one aspect the present invention is directed to mutant Neutrophil Gelatinase Associated Lipocalin (NGAL) proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: In one aspect the present invention is directed to mutant NGAL proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: In one aspect the present invention is directed to mutant Neutrophil Gelatinase Associated Lipocalin (NGAL) proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: In some embodiments, the present invention is directed to compositions and methods for the treatment and prevention of urinary tract infections (UTIs) and urosepsis. In some embodiments, the methods of the invention comprise administering to a subject in need thereof a therapeutically effective amount of an agent that stimulates genito-urinary tract epithelial cells to produce NGAL, and/or an NGAL protein or a functional derivative thereof, and optionally also administering to the subject an additional agent useful for treating or preventing UTI or urosepsis. In other embodiments, the present invention also provides methods of screening for agents that stimulate urinary tract epithelial cells to produce NGAL.

Abstract: In one aspect the present invention is directed to mutant NGAL proteins that have the ability to bind to siderophores, such as enterochelin, and to chelate and transport iron, and that are excreted in the urine. Such NGAL mutants, and complexes thereof with siderophores, can be used to clear excess iron from the body, for example in the treatment of iron overload. The NGAL mutants of the invention also have antibacterial activity and can be used in the treatment of bacterial infections, such as those of the urinary tract.

Abstract: A high molecular weight form of Ngal is provided which can be used to diagnose chronic kidney disease. High molecular weight Ngal is about 75 kDa to about 350 kDa, and comprises non-Ngal proteins, such as polymeric immunoglobulin receptor, alpha-2-macroglobulin and immunoglobulin heavy chain. Methods are disclosed for assessing high molecular weight Ngal in a diagnostic sample from a subject.

Abstract: In some embodiments, the present invention is directed to compositions and methods for the treatment and prevention of urinary tract infections (UTIs) and urosepsis. In some embodiments, the methods of the invention comprise administering to a subject in need thereof a therapeutically effective amount of an agent that stimulates genito-urinary tract epithelial cells to produce NGAL, and/or an NGAL protein or a functional derivative thereof, and optionally also administering to the subject an additional agent useful for treating or preventing UTI or urosepsis. In other embodiments, the present invention also provides methods of screening for agents that stimulate urinary tract epithelial cells to produce NGAL.

Abstract: Methods for diagnosis of sepsis very low birth weight (VLBW) infants are disclosed. The diagnostic methods for sepsis are based on determining whether a bodily fluid sample, such as a urine sample, contains an amount of neutrophil gelatinase-associated lipocalin (NGAL) protein that exceeds or is less than a certain threshold level, or that falls within a certain range. The present invention also provides methods for monitoring the progression of sepsis, methods for monitoring sepsis treatment, methods of distinguishing between true-positive and false culture-positive sepsis, and kits for diagnosing sepsis in VLBW infants.

Abstract: Methods for diagnosis of and distinguishing between, urosepsis, sepsis, and urinary tract infections (UTIs) are disclosed The diagnostic methods are based on determining the level of NGAL protein in a bodily fluid sample, such as urine sample.

Abstract: The present invention is directed to methods for diagnosis of HIVAN, and to methods for distinguishing between HIVAN and other kidney diseases, based on the presence in a bodily fluid, such as urine, of a level of NGAL protein that exceeds a threshold level. The present invention is also directed to methods for diagnosis of HIVAN based on the differential expression of NGAL and one or more other markers, such as uL-FABP or KIM-1, and to methods of diagnosis based on a specific localization of NGAL in microcysts or microcystic tubules of the kidney.

Abstract: The invention provides compositions comprising a lipocalin, such as NGAL, and a mammalian siderophore that are useful as iron chelators and iron donors. The invention also provides mammalian siderophore compounds of Formula (I): The invention further provides, methods of treatment and methods of diagnosis.