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
• correlating said level of said Pro-Enkephalin fragments 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. 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 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
• (a) correlating said level of Pro-Enkephalin or fragments thereof with kidney function in said subject, or
• (b) correlating said level of Pro-Enkephalin or fragments thereof 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 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 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 fragments thereof is 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,
• wherein the level of Pro-Enkephalin or fragments thereof is determined by using an assay comprising a binder, wherein the binder is selected from the group consisting of an antibody, an antibody fragment, or a non-Ig-Scaffold that does not bind to enkephalin peptides [Met]enkephalin SEQ ID No:3.

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
• (a) correlating said level of Pro-Enkephalin or fragments thereof with kidney function in a subject, or
• (b) correlating said level of Pro-Enkephalin or fragments thereof 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 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 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 is 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,
• wherein the level of Pro-Enkephalin or fragments thereof is determined by using an assay with an assay sensitivity 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, said method comprising:

• determining the level of Pro-Enkephalin or fragments thereof in a sample of bodily fluid obtained from a subject using an assay comprising an antibody that binds to Pro-Enkephalin or fragments thereof;
• wherein said Pro-Enkephalin or fragment is 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
• correlating said level of Pro-Enkephalin or fragments thereof 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 a level below a certain threshold is predictive for a success of therapy or intervention.