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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001854-24-NL

Enrollment

Registered

2019-07-17

Start date

2019-08-07

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

kidney transplantation vaccination responses

Interventions

Trade Name: Pneumovax23 Product Name: Pneumovax23 Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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’, NL46834.078.14. - able to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: A potential subject who is unable to give written informed consent will be excluded from participation in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To compare long-term outcomes in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil (TAC vs TAC/MMF). a.Renal function and proteinuria. b.Patient survival. c.Rejection episodes. d.Infectious complications. e.Malignancy (Skin and Non-skin). ;Secondary Objective: 1.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). 2.To investigate protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). ;Primary end point(s): 1.Long-term outcomes in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil (TAC vs TAC/MMF). a.Renal function and proteinuria. b.Patient survival. c.Rejection episodes. d.Infectious complications. e.Malignancy (Skin and Non-skin). ;Timepoint(s) of evaluation of this end point: From inclusion 4 years after kidney transplantation till six years after kidney transplantation.	—

Measure

Time frame

Main Objective: 1.To compare long-term outcomes in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil (TAC vs TAC/MMF). a.Renal function and proteinuria. b.Patient survival. c.Rejection episodes. d.Infectious complications. e.Malignancy (Skin and Non-skin). ;Secondary Objective: 1.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). 2.To investigate protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). ;Primary end point(s): 1.Long-term outcomes in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil (TAC vs TAC/MMF). a.Renal function and proteinuria. b.Patient survival. c.Rejection episodes. d.Infectious complications. e.Malignancy (Skin and Non-skin). ;Timepoint(s) of evaluation of this end point: From inclusion 4 years after kidney transplantation till six years after kidney transplantation.

—

Secondary

Measure	Time frame
Secondary end point(s): 1. The incidence and course of donor-specific antibodies in low-risk kidney transplant recipients beyond one year after transplantation (TAC vs TAC/MMF comparison). 2. The protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). ;Timepoint(s) of evaluation of this end point: From inclusion 4 years after kidney transplantation till six years after kidney transplantation.	—

Measure

Time frame

Secondary end point(s): 1. The incidence and course of donor-specific antibodies in low-risk kidney transplant recipients beyond one year after transplantation (TAC vs TAC/MMF comparison). 2. The protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). ;Timepoint(s) of evaluation of this end point: From inclusion 4 years after kidney transplantation till six years after kidney transplantation.

—

Countries

Netherlands

Contacts

Public ContactAE de Weerd

Erasmus Medical Center

a.deweerd@erasmusmc.nl00310618834197

Outcome results

None listed

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