ong-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.
Phase 4
- Conditions
- kidney transplantation and rejection100214601000401810038430
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 76
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
unable to give written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. To compare long-term outcomes in low-risk kidney transplant recipients on<br /><br>tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate<br /><br>mofetil.<br /><br>a. Renal function and proteinuria.<br /><br>b. Patient survival.<br /><br>c. Rejection episodes<br /><br>d. Infectious complications.<br /><br>e. Malignancy<br /><br>i. Skin<br /><br>ii. Non-skin.</p><br>
- Secondary Outcome Measures
Name Time Method <p>2. To investigate the incidence and course of donor-specific antibodies in<br /><br>low-risk kidney transplant recipients beyond one year after transplantation<br /><br>(TAC vs TAC/MMF comparison).<br /><br>3. To investigate protective antibody responses after pneumococcal vaccination<br /><br>in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs<br /><br>TAC/MMF comparison).<br /><br>a. The persistence of this vaccination response 3 and 5 years after vaccination.<br /><br>b. The boosting effect of a repeated pneumococcal vaccination response five<br /><br>years after initial vaccination.<br /><br>c. The persistence of this boosted response one year after re-vaccination.</p><br>