MoMoTxRes: Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

Sponsor
Odense University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01515605
Collaborator
(none)
1,000
1
155
6.5

Study Details

Study Description

Brief Summary

Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from patients after kidney transplantation. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.

Routine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques. Data are analyzed by descriptive statistics. Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and Dunn's multiple comparison post-test, as appropriate. Associations between variables are analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact test.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from recipients after kidney transplantation and donors. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.

    Routine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years, after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation
    Actual Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients after kidney transplantation

    Patients after kidney transplantation

    Outcome Measures

    Primary Outcome Measures

    1. Cellular transcripts [Day1]

      Transcripts and protein

    Secondary Outcome Measures

    1. Cellular transcripts [Day8]

      Transcripts and protein

    2. Cellular transcripts [Day15]

      Transcripts and protein

    3. Cellular transcripts [Day22]

      Transcripts and protein

    4. Cellular transcripts [Day29]

      Transcripts and protein

    5. Plasma proteome [Day1]

      Plasma Proteome

    6. Plasma proteome [Day8]

      Plasma proteome

    7. Plasma proteome [Day15]

      Plasma proteome

    8. Plasma proteome [Day22]

      Plasma proteome

    9. Plasma proteome [Day29]

      Plasma proteome

    10. Urine proteome [Day1]

      Urine proteome

    11. Urine proteome [Day8]

      Urine proteome

    12. Urine proteome [Day15]

      Urine proteome

    13. Urine proteome [Day22]

      Urine proteome

    14. Urine proteome [Day29]

      Urine proteome

    15. Association of kidney function, glomerular filtration rate, infections, therapy [Day29]

      Association of kidney function, glomerular filtration rate, infections, therapy

    16. Association of kidney function, glomerular filtration rate, infections, therapy [Month6]

      Association of kidney function, glomerular filtration rate, infections, therapy

    17. Association of kidney function, glomerular filtration rate, infections, therapy [Month12]

      Association of kidney function, glomerular filtration rate, infections, therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients after kidney transplantation, male, female, informed consent
    Exclusion Criteria:
    • Deny of informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense DK Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Principal Investigator: Martin Tepel, Dr, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martin Tepel, Dr, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT01515605
    Other Study ID Numbers:
    • MoMoTxRes
    First Posted:
    Jan 24, 2012
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2021