Method for diagnosing or monitoring kidney function or diagnosing kidney dysfunction

A method comprising

• determining the level of Pro-Enkephalin fragments in a bodily fluid obtained from a subject using a binder to said Pro-Enkephalin fragments;
• and
• determining at least one additional clinical parameter from said subject that is age, BUN, NGAL, Creatinine Clearance, Creatinine or Apache Score,
• correlating said level of said Pro-Enkephalin fragments and at least one additional clinical parameter with
• kidney function in said subject, or
• kidney dysfunction in said subject, wherein an elevated level above a certain threshold is predictive or diagnostic for kidney dysfunction in said subject, or
• risk of an adverse event in a subject with kidney disease, wherein an elevated level above a certain threshold is predictive for an enhanced risk of said adverse events, or
• success of a therapy or intervention in a subject with kidney disease, wherein a level below a certain threshold is predictive for a success of therapy or intervention,
• wherein said Pro-Enkephalin fragments is one or more of SEQ ID No. 1, SEQ ID No. 2, SEQ ID No. 5, SEQ ID No. 6, SEQ ID No. 8, SEQ ID No. 9, SEQ ID No. 10 or SEQ ID No. 11
• and
• wherein said binder binds to a region within an amino acid sequence selected from the group consisting of SEQ ID No. 1, 2, 5, 6, 7, 8, 9, 10 and 11 and does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:3.

A method for (a) diagnosing or monitoring kidney function in a subject or (b) diagnosing kidney dysfunction in a subject or (c) predicting or monitoring the risk of an adverse events in a subject, wherein said adverse event is selected from the group comprising worsening of kidney dysfunction including kidney failure, loss of kidney function and end-stage kidney disease or death due to kidney dysfunction including kidney failure, loss of kidney function and end-stage kidney disease or (d) predicting or monitoring the success of a therapy or intervention comprising

• determining the level of Pro-Enkephalin or fragments thereof in a bodily fluid obtained from said subject;
• and determining at least one additional clinical parameter that is age, BUN, NGAL, Creatinine Clearance, Creatinine or Apache Score;
• and
• (a) correlating said level of Pro-Enkephalin or fragments and at least one additional clinical parameter thereof with kidney function in said subject, or
• (b) correlating said level of Pro-Enkephalin or fragments thereof and at least one additional clinical parameter with kidney dysfunction, wherein an elevated level above a certain threshold is predictive or diagnostic for kidney dysfunction in said subject, or
• (c) correlating said level of Pro-Enkephalin or fragments thereof and at least one additional clinical parameter with said risk of an adverse event in a subject with kidney disease, wherein an elevated level above a certain threshold is predictive for an enhanced risk of said adverse events, or
• (d) correlating said level of Pro-Enkephalin or fragments thereof and at least one additional clinical parameter with success of a therapy or intervention in a subject with kidney disease, wherein a level below a certain threshold is predictive for a success of therapy or intervention,
• wherein said Pro-Enkephalin or fragment thereof is one or more of SEQ ID No. 1, SEQ ID No. 2, SEQ ID No. 5, SEQ ID No. 6, SEQ ID No. 8, SEQ ID No. 9, SEQ ID No. 10 or SEQ ID No. 11,
• wherein the level of Pro-Enkephalin or fragments thereof is determined by using an assay comprising a binder that does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:
• 3, wherein said binder is an antibody, an antibody fragment, or a non-Ig-Scaffold.

A method for (a) diagnosing or monitoring kidney function in subject or (b) diagnosing kidney dysfunction in a subject or (c) predicting or monitoring the risk of an adverse events in a subject wherein said adverse event is selected from the group comprising worsening of kidney dysfunction including kidney failure, loss of kidney function and end-stage kidney disease or death due to kidney dysfunction including kidney failure, loss of kidney function and end-stage kidney disease or (d) predicting or monitoring the success of a therapy or intervention comprising

• determining the level of Pro-Enkephalin or fragments thereof in a bodily fluid obtained from said subject and determining at least one additional clinical parameter that is age, BUN, NGAL, Creatinine Clearance, Creatinine or Apache Score and
• (a) correlating said level of Pro-Enkephalin or fragments thereof and at least one additional clinical parameter with kidney function in a subject, or
• (b) correlating said level of Pro-Enkephalin or fragments thereof at least one additional clinical parameter with kidney dysfunction, wherein an elevated level above a certain threshold is predictive or diagnostic for kidney dysfunction in said subject, or
• (c) correlating said level of Pro-Enkephalin or fragments thereof at least one additional clinical parameter with said risk of an adverse event in a subject with kidney disease, wherein an elevated level above a certain threshold is predictive for an enhanced risk of said adverse events, or
• (d) correlating said level of Pro-Enkephalin or fragments thereof at least one additional clinical parameter with success of a therapy or intervention in a subject with kidney disease, wherein a level below a certain threshold is predictive for a success of therapy or intervention,
• wherein said Pro-Enkephalin or fragment thereof is one or more of SEQ ID No. 1, SEQ ID No. 2, SEQ ID No. 5, SEQ ID No. 6, SEQ ID No. 8, SEQ ID No. 9, SEQ ID No. 10 or SEQ ID No. 11,
• wherein the level of Pro-Enkephalin or fragments thereof of is determined by using an assay with at least one binder to Pro-Enkephalin or fragments thereof that does not bind to SEQ ID No.:
• 3, and wherein the sensitivity of the assay is able to quantify the Pro-Enkephalin or Pro-Enkephalin fragments of healthy subjects and is<15 pmol/L.

A method for diagnosing or monitoring kidney function using a kit or assay to detect Pro-Enkephalin or fragments thereof in a subject, wherein said kit or assay comprises at least one antibody capable of binding Pro-Enkephalin or fragments thereof in a sample of bodily fluid obtained from said subject which does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:

• 3, said method comprising:
• determining the level of Pro-Enkephalin or fragments thereof of in a sample of bodily fluid obtained from a subject using a kit or assay comprising an antibody that binds to Pro-Enkephalin or fragments thereof which does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:
• 3,
• and additionally
• using an assay for determining the level of at least one additional clinical parameter that is BUN, NGAL, Creatinine Clearance, Creatinine or Apache Score and correlating said level of Pro-Enkephalin or fragments thereof and at least one additional clinical parameter with
• kidney function in a subject, or
• kidney dysfunction wherein an elevated level above a certain threshold is predictive or diagnostic for kidney dysfunction in said subject, or
• risk of an adverse event in a subject with kidney disease, wherein an elevated level above a certain threshold is predictive for an enhanced risk of said adverse event, or
• success of a therapy or intervention in a subject with kidney disease,
• wherein said Pro-Enkephalin or fragment thereof is SEQ ID No. 1, and optionally one or more of SEQ ID No. 2, SEQ ID No. 5, SEQ ID No. 6, SEQ ID No. 8, SEQ ID No. 9, SEQ ID No. 10 or SEQ ID No. 11.

A method of using a kit or assay to detect Pro-Enkephalin or fragments thereof in a subject, wherein said Pro-Enkephalin or fragment is one or more of SEQ ID No. 1, SEQ ID No. 2, SEQ ID No. 5, SEQ ID No. 6, SEQ ID No. 8, SEQ ID No. 9, SEQ ID No. 10 or SEQ ID No. 11, and wherein said kit or assay comprises at least one antibody capable of binding Pro-Enkephalin or fragments thereof in a sample of bodily fluid obtained from said subject, which does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:

• 3,
• said method comprising:
• determining the level of Pro-Enkephalin or fragments thereof in a sample of bodily fluid obtained from a subject using at least one antibody within said kit or assay that binds to Pro-Enkephalin or fragments thereof which does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:
• 3,
• wherein
• a level of Pro-Enkephalin or fragments thereof below 80 pmol/L is predictive for a success of therapy or intervention or,
• a level of Pro-Enkephalin or fragments thereof above 80 pmol/L is correlated with a risk of death or an adverse event in a subject or
• a level of Pro-Enkephalin or fragments thereof above 80 pmol/L is predictive or diagnostic for kidney dysfunction in said subject.