Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

Conditions
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Transplantation Infection, Kidney Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after kidney transplantation, male, female, informed consent Exclusion Criteria: Deny of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients after kidney transplantation<br>Patients after kidney transplantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular transcripts | Transcripts and protein | Day1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular transcripts | Transcripts and protein | Day8 | 
| Cellular transcripts | Transcripts and protein | Day15 | 
| Cellular transcripts | Transcripts and protein | Day22 | 
| Cellular transcripts | Transcripts and protein | Day29 | 
| Plasma proteome | Plasma Proteome | Day1 | 
| Plasma proteome | Plasma proteome | Day8 | 
| Plasma proteome | Plasma proteome | Day15 | 
| Plasma proteome | Plasma proteome | Day22 | 
| Plasma proteome | Plasma proteome | Day29 | 
| Urine proteome | Urine proteome | Day1 | 
| Urine proteome | Urine proteome | Day8 | 
| Urine proteome | Urine proteome | Day15 | 
| Urine proteome | Urine proteome | Day22 | 
| Urine proteome | Urine proteome | Day29 | 
| Association of kidney function, glomerular filtration rate, infections, therapy | Association of kidney function, glomerular filtration rate, infections, therapy | Day29 | 
| Association of kidney function, glomerular filtration rate, infections, therapy | Association of kidney function, glomerular filtration rate, infections, therapy | Month6 | 
| Association of kidney function, glomerular filtration rate, infections, therapy | Association of kidney function, glomerular filtration rate, infections, therapy | Month12 |