Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

Kidney Diseases Clinical Trial

— MoMoTxRes  

Official title:

Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01515605
• Other study ID #: MoMoTxRes
• Status: Recruiting
• Start date: January 1, 2011
• Est. completion date: March 31, 2033

Study information

• Verified date: March 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 31, 2033
• Est. primary completion date: March 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Deny of informed consent

Related Conditions & MeSH terms

• Kidney Diseases
• Transplantation Infection

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	DK

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular transcripts	Transcripts and protein	Day1
Secondary	Cellular transcripts	Transcripts and protein	Day8
Secondary	Cellular transcripts	Transcripts and protein	Day15
Secondary	Cellular transcripts	Transcripts and protein	Day22
Secondary	Cellular transcripts	Transcripts and protein	Day29
Secondary	Plasma proteome	Plasma Proteome	Day1
Secondary	Plasma proteome	Plasma proteome	Day8
Secondary	Plasma proteome	Plasma proteome	Day15
Secondary	Plasma proteome	Plasma proteome	Day22
Secondary	Plasma proteome	Plasma proteome	Day29
Secondary	Urine proteome	Urine proteome	Day1
Secondary	Urine proteome	Urine proteome	Day8
Secondary	Urine proteome	Urine proteome	Day15
Secondary	Urine proteome	Urine proteome	Day22
Secondary	Urine proteome	Urine proteome	Day29
Secondary	Association of kidney function, glomerular filtration rate, infections, therapy	Association of kidney function, glomerular filtration rate, infections, therapy	Day29
Secondary	Association of kidney function, glomerular filtration rate, infections, therapy	Association of kidney function, glomerular filtration rate, infections, therapy	Month6
Secondary	Association of kidney function, glomerular filtration rate, infections, therapy	Association of kidney function, glomerular filtration rate, infections, therapy	Month12