Cincinnati Children's Hospital Medical Center

Columbia University

Prasad Devarajan

Jonathan Matthew Barasch

Kiyoshi Mori

Jörg Köhl

Michael R Bennett

Hermine I Brunner

Thomas L Nickolas

Jonathan Barasch

Jonathan M Barasch

Disclosed are methods of determining whether a patient diagnosed with nephrotic syndrome has steroid sensitive nephrotic syndrome (SSNS) or steroid resistant nephrotic syndrome (SRNS) by determining the levels of one or more biomarkers in a biofluid from the patient. Also disclosed are methods of treating a patient diagnosed with nephrotic syndrome, and kits and substrates related to the disclosed methods.

Compositions and methods for treating steroid resistant nephrotic syndrome and/or steroid sensitive nephrotic syndrome

Methods for the detection of active lupus nephritis (LN) and worsening renal disease activity and/or active LN in patients diagnosed with systemic lupus erythematosus, using a panel of biomarkers including transferrin (Tf), ceruloplasmin (Cp), alpha-1-acid glycoprotein (AGP1), lipocalin-like prostaglandin D synthetase (L-PGDS), and urinary neutrophil gelatinase associated lipocalin (UNGAL).

Detection of worsening renal disease in subjects with systemic lupus erythematosus

A method for the detection of an early biomarker for assessing a change in renal status in a mammalian subject following a renal event. The method typically includes the steps of (a) providing a body fluid sample obtained from a mammalian subject; (b) analyzing the molecular weight of the proteins in the sample using proteome analysis; and (c) identifying the presence of a protein in the sample selected from the group consisting of a 6.4 kDa protein, a 28.5 kDa protein, a 33 kDa protein, a 44 kDa protein, a 67 kDa protein, and combinations thereof. The presence of one of these proteins can serve as an early biomarker for assessing a change in renal status. The levels of these proteins can be compared to predetermined levels, and thus provide a determination of the subject's renal status. The invention also includes a method of assessing the administration of aprotinin during cardio-pulmonary bypass surgery and provides for methods where the level of the 6.4 kDa biomarker in the subject's urine directs a caregiver's therapeutic decision regarding the intra-operative administration of aprotinin.

Method for the early detection of renal disease using proteomics

A preservation solution for organs waiting to be transplanted is disclosed; the method of using the solution in a transplantation procedure is also disclosed. The preservation solutions comprise a balanced isotonic aqueous solution comprising sodium, potassium, calcium, magnesium and bicarbonate ions in a physiologically acceptable amount, together with an effective amount of a mutein of the C5anaphylatoxin which is a C5receptor antagonist wherein the amino acid residue naturally occurring at sequence position 69 is mutated.

Organ transplant solutions and method for transplanting organs

Use of neutrophil gelatinase-associated lipocalin (NGAL) as a therapeutic and in a method of treating, reducing, or ameliorating an injury selected from an ischemic injury, an ischemic-reperfusion injury, and a toxin-induced injury, to an organ in a patient. The invention includes administering to the patient NGAL in an amount effective to treat, reduce or ameliorate ischemic, ischemic-reperfusion, or toxin-induced injury to the organ, such as the kidney. A siderophore can be co-administered with the NGAL. The invention also relates to administering a sideophore to enhance a response to secretion of NGAL following an ischemic or toxin-induced injury to an organ in a patient.

NGAL for reduction and amelioration of ischemic and nephrotoxic injuries

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.

Method for distinguishing between kidney dysfunctions

A method and kit for identifying the presence of an early biomarker of impaired renal status following a renal event in a mammalian subject. The method typically comprises (a) providing a body fluid sample obtained from a mammalian subject following a renal event; and (b) detecting in the provided sample the presence of a protein selected from the group consisting of aprotinin, alpha-1-microglobulin (A1M), alpha-1-acid-glycoprotein (A1AG), microalbumin, and combinations thereof, the presence thereof serving as an early biomarker of a change in renal status. The method can include a kit for point-of-care detection of the early biomarker of impaired renal status. Identification of the presence or absence of the early biomarker typically directs a caregiver's therapeutic decision regarding managing treatment of the subject for impaired renal status. The invention also includes a method of assessing the administration of aprotinin during cardiopulmonary bypass surgery and provides for methods where the level of aprotinin in the subject's urine directs a caregiver's therapeutic decision regarding the intra-operative administration of aprotinin.

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Cincinnati, OH, United States of America

Prasad Devarajan