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

This study is currently recruiting participants.
Verified October 2016 by Martin Tepel, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515605
First Posted: January 24, 2012
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Martin Tepel, Odense University Hospital
  Purpose

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.


Condition
Transplantation Infection Kidney Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Martin Tepel, Odense University Hospital:

Primary Outcome Measures:
  • Cellular transcripts [ Time Frame: Day1 ]

Secondary Outcome Measures:
  • Cellular transcripts [ Time Frame: Day8 ]
  • Cellular transcripts [ Time Frame: Day15 ]
  • Cellular transcripts [ Time Frame: Day22 ]
  • Cellular transcripts [ Time Frame: Day29 ]
  • Plasma proteome [ Time Frame: Day1 ]
  • Plasma proteome [ Time Frame: Day8 ]
  • Plasma proteome [ Time Frame: Day15 ]
  • Plasma proteome [ Time Frame: Day22 ]
  • Plasma proteome [ Time Frame: Day29 ]
  • Urine proteome [ Time Frame: Day1 ]
  • Urine proteome [ Time Frame: Day8 ]
  • Urine proteome [ Time Frame: Day15 ]
  • Urine proteome [ Time Frame: Day22 ]
  • Urine proteome [ Time Frame: Day29 ]
  • Association of measures with glomerular filtration rate [ Time Frame: Day29 ]
  • Association of measures with glomerular filtration rate [ Time Frame: Month6 ]
  • Association of measures with glomerular filtration rate [ Time Frame: Month12 ]

Biospecimen Retention:   Samples With DNA
Blood, urine, tissue

Estimated Enrollment: 1000
Study Start Date: January 2011
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients after kidney transplantation
Patients after kidney transplantation

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Kidney transplantation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Deny of informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515605


Locations
Denmark
Odense University Hospital Recruiting
Odense, DK, Denmark, 5000
Contact: Martin Tepel, Dr    4565503755    mtepel@health.sdu.dk   
Contact: Martin Tepel, Dr    4565503755    martin.tepel@rsyd.dk   
Principal Investigator: Martin Tepel, Dr         
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Martin Tepel, Dr Odense University Hospital
  More Information

Responsible Party: Martin Tepel, Dr, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01515605     History of Changes
Other Study ID Numbers: MoMoTxRes
First Submitted: January 18, 2012
First Posted: January 24, 2012
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases