Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus. Extension study of: Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study.

Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus. Extension study of: Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study. - TACmono long term.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48073

Enrollment

Registered

2019-07-17

Start date

2019-08-16

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

kidney transplantation and rejection

Interventions

1. extra blood tubes will be sampled during routine blood sampling: two vials a 5 ml serum year 4 and 6 after kidney transplantation and one vial a 5 ml serum 7 and 10 years after kidney transplanta

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: recipient of a kidney transplant who has participated in the study: *Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study*, NL 2014-46834.078.14. able to give written informed consent

Exclusion criteria

Exclusion criteria: unable to give written informed consent

Design outcomes

Primary

Measure	Time frame
1. To compare long-term outcomes in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil. a. Renal function and proteinuria. b. Patient survival. c. Rejection episodes d. Infectious complications. e. Malignancy i. Skin ii. Non-skin.	—

Secondary

Measure	Time frame
2. To investigate the incidence and course of donor-specific antibodies in low-risk kidney transplant recipients beyond one year after transplantation (TAC vs TAC/MMF comparison). 3. To investigate protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). a. The persistence of this vaccination response 3 and 5 years after vaccination. b. The boosting effect of a repeated pneumococcal vaccination response five years after initial vaccination. c. The persistence of this boosted response one year after re-vaccination.	—

Measure

Time frame

2. To investigate the incidence and course of donor-specific antibodies in low-risk kidney transplant recipients beyond one year after transplantation (TAC vs TAC/MMF comparison). 3. To investigate protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). a. The persistence of this vaccination response 3 and 5 years after vaccination. b. The boosting effect of a repeated pneumococcal vaccination response five years after initial vaccination. c. The persistence of this boosted response one year after re-vaccination.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)