The antiviral immune response as an indicator of the intensity of immunosuppression and outcome after kidney transplantation

The antiviral immune response as an indicator of the intensity of immunosuppression and outcome after kidney transplantation - VIRENO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013007

Enrollment

200

Registered

2018-01-11

Start date

2018-01-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z94.0 Z52.4

Interventions

Group 1: We are going to perform novel virological assays (BKV serology, CMV T-cell immunity and TTV PCR) before and after kidney transplantation and correlate the results with the outcome after trans

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Incapacity to consent, e.g. for language barriers or psychiatric disorders

Design outcomes

Primary

Measure	Time frame
2 primary endpoints: - Composite endpoint of relevant CMV or BKV infection and hospitalization due to any Kind of infection - Composite endpoint of relevant immunological Events (de-novo DSA and/or biopsy-confirmed rejection)	—

Secondary

Measure	Time frame
- graft function (eGFR 3 weeks, 6 months, 12 months post-transplant) - graft loss within the first year - death within the first year - number of infection episodes until 3 weeks, 6 months and 12 months post transplant - number of hospitalization episodes within the first year - time until events mentioned above - TTV viral load (3 weeks, 6 months post-transplant) - CNI trough level (3 weeks, 6 months and 12 months post-transplant) - mycophenolate dosage (3 weeks, 6 months, 12 months post-transplant) - antiviral medication in a therapeutic intent within the first year - cellular rejection within the first year - ABMR within the first year - borderline rejection within the first year - any kind of rejection within the first year - denovo DSA within the first year - PVAN within the first year - CMV blood viral load (3 weeks, 6 months, 12 months post transplant) - BKV blood viral load (3 weeks, 6 months, 12 months post-transplant)	—

Measure

Time frame

- graft function (eGFR 3 weeks, 6 months, 12 months post-transplant) - graft loss within the first year - death within the first year - number of infection episodes until 3 weeks, 6 months and 12 months post transplant - number of hospitalization episodes within the first year - time until events mentioned above - TTV viral load (3 weeks, 6 months post-transplant) - CNI trough level (3 weeks, 6 months and 12 months post-transplant) - mycophenolate dosage (3 weeks, 6 months, 12 months post-transplant) - antiviral medication in a therapeutic intent within the first year - cellular rejection within the first year - ABMR within the first year - borderline rejection within the first year - any kind of rejection within the first year - denovo DSA within the first year - PVAN within the first year - CMV blood viral load (3 weeks, 6 months, 12 months post transplant) - BKV blood viral load (3 weeks, 6 months, 12 months post-transplant)

—

Countries

Germany

Contacts

Public ContactPatrick Affeldt

Uniklinik KölnKlinik II für Innere Medizin

patrick.affeldt@uk-koeln.de0221- 478 97222

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026