The antiviral immune response as an indicator of the intensity of immunosuppression and outcome after kidney transplantatio
- Conditions
- Z94.0Z52.4Kidney transplant statusKidney donor
- Registration Number
- DRKS00013007
- Lead Sponsor
- niversitätsklinikum Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 205
Inclusion Criteria
Patients who undergo kidney transplantation from the beginning of the recruitment period, regardless of the transplant being from a living or a deceased kidney donor. In the case of a living kidney transplant, we are also going to enrol the kidney donor.
- Written informed consent.
Exclusion Criteria
- Incapacity to consent, e.g. for language barriers or psychiatric disorders
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 primary endpoints:<br>- Composite endpoint of relevant CMV or BKV infection and hospitalization due to any Kind of infection<br>- Composite endpoint of relevant immunological Events (de-novo DSA and/or biopsy-confirmed rejection)
- Secondary Outcome Measures
Name Time Method - graft function (eGFR 3 weeks, 6 months, 12 months post-transplant) <br>- graft loss within the first year <br>- death within the first year <br>- number of infection episodes until 3 weeks, 6 months and 12 months post transplant <br>- number of hospitalization episodes within the first year <br>- time until events mentioned above <br>- TTV viral load (3 weeks, 6 months post-transplant) <br>- CNI trough level (3 weeks, 6 months and 12 months post-transplant) <br>- mycophenolate dosage (3 weeks, 6 months, 12 months post-transplant) <br>- antiviral medication in a therapeutic intent within the first year <br>- cellular rejection within the first year <br>- ABMR within the first year <br>- borderline rejection within the first year <br>- any kind of rejection within the first year <br>- denovo DSA within the first year <br>- PVAN within the first year <br>- CMV blood viral load (3 weeks, 6 months, 12 months post transplant) <br>- BKV blood viral load (3 weeks, 6 months, 12 months post-transplant)