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NCT Number: NCT01515605

Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients after kidney transplantation, male, female, informed consent

Exclusion criteria

  • Deny of informed consent

Treatment and study plan

Primary outcomes

  1. Cellular transcripts

    Time frame: Day1

    Transcripts and protein

Secondary outcomes

  1. Cellular transcripts

    Time frame: Day8

    Transcripts and protein

  2. Cellular transcripts

    Time frame: Day15

    Transcripts and protein

  3. Cellular transcripts

    Time frame: Day22

    Transcripts and protein

  4. Cellular transcripts

    Time frame: Day29

    Transcripts and protein

  5. Plasma proteome

    Time frame: Day1

    Plasma Proteome

  6. Plasma proteome

    Time frame: Day8

    Plasma proteome

  7. Plasma proteome

    Time frame: Day15

    Plasma proteome

  8. Plasma proteome

    Time frame: Day22

    Plasma proteome

  9. Plasma proteome

    Time frame: Day29

    Plasma proteome

  10. Urine proteome

    Time frame: Day1

    Urine proteome

  11. Urine proteome

    Time frame: Day8

    Urine proteome

  12. Urine proteome

    Time frame: Day15

    Urine proteome

  13. Urine proteome

    Time frame: Day22

    Urine proteome

  14. Urine proteome

    Time frame: Day29

    Urine proteome

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

    Time frame: Day29

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

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

    Time frame: Month6

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

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

    Time frame: Month12

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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Acronym: MoMoTxRes

Important dates

Study start
2011
Primary completion
2033
Study completion
2033
First posted
Jan 24, 2012
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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