NCT01515605 Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation
| NCT ID | NCT01515605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Transplantation Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2011-01-01 |
| Primary Completion | 2033-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2011-01-01 with a primary completion date of 2033-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patients after kidney transplantation, male, female, informed consent Exclusion Criteria: * Deny of informed consent
Contact & Investigator
Martin Tepel, Dr
PRINCIPAL INVESTIGATOR
Odense University Hospital
Frequently Asked Questions
Who can join the NCT01515605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transplantation Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01515605 currently recruiting?
Yes, NCT01515605 is actively recruiting participants. Visit ClinicalTrials.gov or contact Odense University Hospital to inquire about joining.
Where is the NCT01515605 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT01515605 clinical trial?
NCT01515605 is sponsored by Odense University Hospital. The principal investigator is Martin Tepel, Dr at Odense University Hospital. The trial plans to enroll 1,500 participants.