Clinical trial NCT01515605: Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation
Official title: Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplantation Infection
Kidney Diseases
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplantation

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Deny of informed consent

Primary outcomes:
measure: Cellular transcripts
timeFrame: Day1
Secondary outcomes:
measure: Cellular transcripts
timeFrame: Day8
measure: Cellular transcripts
timeFrame: Day15
measure: Cellular transcripts
timeFrame: Day22
measure: Cellular transcripts
timeFrame: Day29
measure: Plasma proteome
timeFrame: Day1
measure: Plasma proteome
timeFrame: Day8
measure: Plasma proteome
timeFrame: Day15
measure: Plasma proteome
timeFrame: Day22
measure: Plasma proteome
timeFrame: Day29
measure: Urine proteome
timeFrame: Day1
measure: Urine proteome
timeFrame: Day8
measure: Urine proteome
timeFrame: Day15
measure: Urine proteome
timeFrame: Day22
measure: Urine proteome
timeFrame: Day29
measure: Association of kidney function, glomerular filtration rate, infections, therapy
timeFrame: Day29
measure: Association of kidney function, glomerular filtration rate, infections, therapy
timeFrame: Month6
measure: Association of kidney function, glomerular filtration rate, infections, therapy
timeFrame: Month12
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: DK
Study officials:
affiliation: Odense University Hospital
name: Martin Tepel, Dr
role: PRINCIPAL_INVESTIGATOR
References: