Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation (MoMoTxRes)
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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 |
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 |
Kidney transplantation
Inclusion Criteria:
- Patients after kidney transplantation, male, female, informed consent
Exclusion Criteria:
- Deny of informed consent
Contacts and Locations| Denmark | |
| Odense University Hospital | Recruiting |
| Odense, DK, Denmark, 5000 | |
| Contact: Martin Tepel, Dr 4565503755 mtepel@health.sdu.dk | |
| Principal Investigator: Martin Tepel, Dr | |
| 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 June 18, 2013