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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Martin Tepel, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01515605
First received: January 18, 2012
Last updated: January 24, 2012
Last verified: January 2012
  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 0-1-2-3-4-12-16-52-104 weeks after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3, GATA4, GAPDH, TRPC3 TRPC6, granzyme B, perforin, FOXP3, ISG15, Mx1 MMP3, MMP9 and others) are quantified using standard quantitative RT-PCR techniques. Proteomic analysis were performed in 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 Odense University Hospital:

Biospecimen Retention:   Samples With DNA

Blood, urine, tissue


Estimated Enrollment: 1000
Study Start Date: January 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients after kidney transplantation

Detailed Description:

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 0-1-2-3-4-12-16-52-104 weeks after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3, GATA4, GAPDH, TRPC3 TRPC6, granzyme B, perforin, FOXP3, ISG15, Mx1 MMP3, MMP9 and others) are quantified using standard quantitative RT-PCR techniques. Proteomic analysis were performed in urine samples. Polymorphisms of selected genes are analyzed using standard techniques.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515605

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

No publications provided

Responsible Party: Martin Tepel, Dr, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01515605     History of Changes
Other Study ID Numbers: MoMoTxRes
Study First Received: January 18, 2012
Last Updated: January 24, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014