Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation (MoMoTxRes)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Transplantation Infection

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Odense, DK, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Martin Tepel, Dr; Phone Number: 4565503755; Email: mtepel@health.sdu.dk
      • Contact: Martin Tepel, Dr; Phone Number: 4565503755; Email: martin.tepel@rsyd.dk
      • Principal Investigator: Martin Tepel, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Kidney transplantation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Deny of informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients after kidney transplantation

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Anticipated): March 31, 2033
• Study Completion (Anticipated): March 31, 2033

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: MoMoTxRes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO