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A randomized trial of tacrolimus monotherapy compared to standard triple immune suppressive medication in elderly recipients of a kidney transplant to reduce infection-related mortality and improve quality of life; the TACMONO-XL study.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517709-10-00
Enrollment
304
Registered
2025-06-06
Start date
2025-08-04
Completion date
Unknown
Last updated
2025-06-06

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

Conditions

kidney transplantation

Brief summary

- death by infectious disease - infectious burden defined as the number of infections requiring hospitalization and/or proven viral infections including cytomegalovirus and BK-virus replication within a follow-up of 3 years.

Detailed description

- quality of life - biopsy-proven rejection from time of randomization to end of follow-up at 3 years post-transplantation. - Assessment of de novo alloantibody formation as detected by a Luminex-based assay (6 months, 1,2 and 3 years after transplantation) - Assessment of the circulating alloreactive T cells in time (before, 1, 2 and 3 years after transplantation) - Graft function measured by eGFR and 24-hr urine collection - Patient and graft survival

Interventions

DRUGPREDNISONE
DRUGMYCOPHENOLATE MOFETIL
DRUGTACROLIMUS

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- death by infectious disease - infectious burden defined as the number of infections requiring hospitalization and/or proven viral infections including cytomegalovirus and BK-virus replication within a follow-up of 3 years.

Secondary

MeasureTime frame
- quality of life - biopsy-proven rejection from time of randomization to end of follow-up at 3 years post-transplantation. - Assessment of de novo alloantibody formation as detected by a Luminex-based assay (6 months, 1,2 and 3 years after transplantation) - Assessment of the circulating alloreactive T cells in time (before, 1, 2 and 3 years after transplantation) - Graft function measured by eGFR and 24-hr urine collection - Patient and graft survival

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026