Methods and kits for predicting a response to an erythropoietic agent

• US 9,057,731 B2
• Filed: 06/23/2011
• Issued: 06/16/2015
• Est. Priority Date: 06/23/2010
• Status: Active Grant

• Current Assignee: University of Louisville
• Original Assignee: University of Louisville
• Inventors: Merchant, Michael L., Klein, Jon B., Brier, Michael E., Gaweda, Adam E.
• Primary Examiner(s): FOSTER, CHRISTINE E
• Application Number:
  US13/167,478
• Publication Number:
  US 20110318761A1
• Time in Patent Office: 1,454 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: G01N 2333/47 Assays involving proteins of known structure or function as defined in the subgroups
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/6863 Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

Methods for predicting a response to an erythropoietic agent in a subject include providing a biological sample from the subject, and determining an amount in the sample of at least one peptide selected from the group consisting of SEQ ID NOS: 1-17. If there is a measurable difference in the amount of the at least one peptide in the sample, when compared to a control level of the same peptide, the subject is then predicted to have a good response or a poor response to the erythropoietic agent. Kits for predicting a response to an erythropoietic agent are further provided and include one or more antibodies, or fragments thereof, that specifically recognize a peptide of SEQ ID NOS: 1-17.

Claims

1. A method for predicting a response that a subject to be administered an erythropoietic agent would have to the administered erythropoietic agent, the method comprising:

(a) providing a serum sample from the subject;

(b) measuring an amount in the sample of the peptide consisting of SEQ ID NO;

13;

(c) comparing the amount of the peptide in the sample to a control level of the peptide;

(d) predicting that the subject will have a good response to the erythropoietic agent when there is a measurable increase in the amount of the peptide consisting of SEQ ID NO;

13 in the sample as compared to the control level; and

(e) administering an amount of the erythropoietic agent to the subject based on the results of the predicting step (d), wherein a differing amount of the erythropoietic agent is administered when the subject is predicted to have a good response relative to the amount of the erythropoietic agent administered when the subject is not predicted to have a good response.

2. The method of claim 1, further comprising determining whether there is a measureable difference in the amount of the peptide consisting of SEQ ID NO:

13 in the sample as compared to the amount of the at least one peptide in a good responder and/or a poor responder, as an indicator of the subject'"'"'s predicted response.

3. The method of claim 1, further comprising applying the biological sample to a device capable of affecting detection of the peptide consisting of SEQ ID NO:

13.

4. The method of claim 1, wherein the subject has kidney disease, anemia, or cancer.

5. The method of claim 1, wherein the subject is human.

6. The method of claim 1, wherein determining the amount In the sample of the at least one peptide comprises determining the amount in the sample of the at least one peptide using mass spectrometry (MS) analysis, immunoassay analysis, or both.

7. The method of claim 6, wherein the immunoassay analysis comprises an enzyme-linked immunosorbent assay (ELISA).

8. The method of claim 1, further comprising, prior to (a), selecting a subject for treatment with an erythropoietic agent.