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.
interventional
N/A
1 country
4
Lowering the immune suppressive maintenance regimen in the elderly recipient thereby reducing infection-related mortality and morbidity
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2024
Actual (reported)- 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.
- 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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
MYCOPHENOLATE MOFETIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
COATED TABLET
View registry recordFormulated product
TACROLIMUS
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
MYCOPHENOLATE MOFETIL
Named ingredient: Mycophenolate mofetil
View registry recordTACROLIMUS
Named ingredient: Tacrolimus
View registry recordPREDNISONE
Named ingredient: Prednisone
View registry recordErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
rotterdam, 3015GD, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Amsterdam UMC Stichting
Amsterdam, 1105 AZ, Netherlands
Michiel Betjes
First Submitted
October 25, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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university medical center Utrecht
Utrecht, 3584 CX, Netherlands