Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

NCT ID: NCT01515605

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2033-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transplantation Infection Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients after kidney transplantation

Patients after kidney transplantation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Deny of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martin Tepel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Tepel, Dr

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Odense University Hospital

Odense, DK, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Martin Tepel, Dr

Role: primary

4565503755

Martin Tepel, Dr

Role: backup

4565503755

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MoMoTxRes

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.