Detection of NGAL in chronic renal disease
First Claim
1. A method for the detection of worsening chronic renal failure in a mammal, comprising the steps of:
- 1) providing a baseline fluid sample from a mammalian subject;
2) providing at least one subsequent fluid sample from the subject;
3) detecting the quantity of NGAL in each sample; and
4) comparing the quantity of NGAL in the subsequent sample to the quantity of NGAL in the baseline sample, an increased quantity in the subsequent sample indicating that renal tubular cell injury is worsening in the subject.
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Accused Products
Abstract
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.
65 Citations
20 Claims
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1. A method for the detection of worsening chronic renal failure in a mammal, comprising the steps of:
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1) providing a baseline fluid sample from a mammalian subject;
2) providing at least one subsequent fluid sample from the subject;
3) detecting the quantity of NGAL in each sample; and
4) comparing the quantity of NGAL in the subsequent sample to the quantity of NGAL in the baseline sample, an increased quantity in the subsequent sample indicating that renal tubular cell injury is worsening in the subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of monitoring the effectiveness of a treatment for chronic renal failure in a mammal, comprising the steps of:
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1) providing a baseline fluid sample from a mammalian subject experiencing chronic renal failure;
2) providing a treatment for chronic renal failure to the subject;
3) providing at least one post-treatment fluid sample from the subject; and
4) detecting for an increased quantity of NGAL in the post-treatment fluid sample as compared to the quantity of NGAL in the baseline fluid sample. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. A method of identifying the extent of chronic renal failure in a mammal over time, comprising the steps of:
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1) providing at least one baseline fluid sample from a mammalian subject at a first time;
2) providing at least one subsequent fluid sample from the subject at a time which is subsequent to the first time;
3) comparing the quantity of NGAL in the subsequent sample to the quantity of NGAL in the baseline sample; and
4) determining the extent of the chronic renal failure in the subject over time based on the time for onset of the increased quantity of NGAL in the subsequent fluid sample, relative to the baseline sample. - View Dependent Claims (18, 19, 20)
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Specification