Thomas P Nickolas

20070037232, Feb 15, 2007

Oct 13, 2005

11/374285

Jonathan Barasch - New York NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas Nickolas - Brooklyn NY, US
Kiyoshi Mori - Kyoto, JP

G01N 33/53

435007920

Methods of assessing the ongoing kidney status in a subject afflicted with chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in fluid samples over time is disclosed. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the urine and serum as a result of chronic renal tubule cell injury. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid the clinical practitioner in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

20080014644, Jan 17, 2008

Jun 28, 2007

11/770214

Jonathan BARASCH - New York City NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas Nickolas - Brooklyn NY, US
Kiyoshi Mori - Kita-ku, JP

G01N 33/48

436063000

A method of assessing the ongoing kidney status of a mammal afflicted with or at risk of developing chronic renal injury or disease, including chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in urine, serum or plasma samples at discrete time periods, as well as over time. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening chronic renal disease or CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid the clinical practitioner in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

20080090304, Apr 17, 2008

Jun 28, 2007

11/770245

Jonathan Matthew BARASCH - New York City NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas L. Nickolas - Brooklyn NY, US
Kiyoshi Mori - Kita-ku, JP

G01N 33/53
G01N 33/68

436501, 436 86

A method of assessing the ongoing kidney status of a mammal afflicted with or at risk of developing chronic renal injury or disease, including chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in urine, serum or plasma samples at discrete time periods, as well as over time. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening chronic renal disease or CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid the clinical practitioner in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

20090215094, Aug 27, 2009

Apr 1, 2009

12/416225

Jonathan Matthew BARASCH - New York City NY, US
Prasad DEVARAJAN - Cincinnati OH, US
Thomas L. NICKOLAS - Brooklyn NY, US
Kiyoshi MORI - Kita-ku, JP

G01N 33/573
G01N 33/68

435 792, 436 86

A method of assessing the ongoing kidney status of a mammal afflicted with or at risk of developing chronic renal injury or disease, including chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in urine, serum or plasma samples at discrete time periods, as well as over time. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening chronic renal disease or CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid the clinical practitioner in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

20090298047, Dec 3, 2009

Jun 21, 2008

12/143769

Jonathan Matthew Barasch - New York City NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas L. Nickolas - Brooklyn NY, US

C12Q 1/25

435 4

A method for distinguishing between kidney dysfunctions in a mammal, including pre-renal azotemia, an acute renal injury that may progress to acute renal failure, and chronic kidney disease, using a urinary or circulating NGAL assay result that is compared to a predetermined NGAL cutoff level, and a single serum or plasma creatinine measurement. Typically the single creatinine measurement cannot distinguish acute renal injury from chronic kidney disease or pre-renal azotemia, a single measurement of urinary NGAL, combined with the single serum or plasma creatinine measurement, has sufficient sensitivity and specificity to distinguish acute renal injury from normal function, prerenal azotemia, and chronic kidney disease and predicts poor inpatient outcomes. Patients admitted to the emergency department of the hospital with any of acute kidney injury, prerenal azotemia, chronic kidney disease, or even normal kidney function, can be evaluated based on the single measurements of urinary or circulating NGAL, and serum or plasma creatinine. Urinary NGAL level is highly predictive of clinical outcomes, including nephrology consultation, dialysis, and admission to the intensive care unit.

20100015648, Jan 21, 2010

Sep 28, 2009

12/567860

Jonathan Matthew Barasch - New York NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas L. Nickolas - Brooklyn NY, US
Kiyoshi Mori - Kita-ku, JP

G01N 33/53

435 792, 435 71

Methods of assessing the ongoing kidney status in a subject afflicted with chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in fluid samples over time is disclosed. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the urine and serum as a result of chronic renal tubule cell injury. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid the clinical practitioner in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

20100184089, Jul 22, 2010

Mar 30, 2010

12/750241

Jonathan Matthew BARASCH - New York City NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas L. Nickolas - Brooklyn NY, US
Kiyoshi Mori - Kita-ku, JP

G01N 33/573
G01N 33/566

435 74, 436501

A method of assessing the ongoing kidney status of a mammal afflicted with or at risk of developing chronic renal injury or disease, including chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in urine, serum or plasma samples at discrete time periods, as well as over time. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening chronic renal disease or CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid the clinical practitioner in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

20100233739, Sep 16, 2010

Feb 12, 2010

12/704875

Jonathan BARASCH - New York NY, US
Thomas L. NICKOLAS - New York NY, US

G01N 33/53
G01N 33/00

435 792, 436 86

In one embodiment, the present invention is directed to methods for diagnosis of urinary tract obstruction (UTO), and to methods for distinguishing between unilateral and bilateral UTO. In some aspects, the diagnostic methods of the invention are based on determining whether a bodily fluid sample, such as a urine sample, contains an amount of NGAL protein that exceeds or is less than a certain threshold level, or that falls within a certain range. The present invention also provides diagnostic kits for the diagnosis of UTO and for distinguishing between unilateral and bilateral UTO.