E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
kidney transplantation vaccination responses |
niertransplantatie vaccinatie responsen |
|
E.1.1.1 | Medical condition in easily understood language |
kidney transplantation vaccination responses |
niertransplantatie vaccinatie responsen |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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).
|
1. Het vergelijken van de lange termijn uitkomsten in niertransplantatie patiënten met tacrolimus versus tacrolimus met mycofenolaat mofetil (TAC vs TAC/MMF). a. nierfunctie en proteinuria b. patient overleving c. afstoting d. infectieuze complicaties e. maligniteiten (huid vs niet-huid) |
|
E.2.2 | Secondary objectives of the trial |
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).
|
1. Het bestuderen van de incidentie en beloop van donor-specifieke antistoffen in niertransplantatie patiënten met een immunologisch laag risico na één jaar na niertransplantatie. 2. Het bestuderen van beschermende antistof responsen na pneumococcen vaccinatie in patiënten met TAC vs TAC/MMF. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
- niertransplantatie ontvanger die heeft deelgenomen aan de studie: ‘Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study’, NL46834.078.14.
- in staat tot het geven van schriftelijke 'informed consent'. |
|
E.4 | Principal exclusion criteria |
A potential subject who is unable to give written informed consent will be excluded from participation in this study.
|
niet in staat zijn tot het geven van schriftelijke 'informed consent'. |
|
E.5 End points |
E.5.1 | 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).
|
1. Lange termijn uitkomsten in niertransplantatie patiënten met tacrolimus versus tacrolimus met mycofenolaat mofetil (TAC vs TAC/MMF). a. nierfunctie en proteinuria b. patient overleving c. afstoting d. infectieuze complicaties e. maligniteiten (huid vs niet-huid) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From inclusion 4 years after kidney transplantation till six years after kidney transplantation. |
vanf inclusie 4 jaar na niertransplantatie tot zes jaar na niertransplantatie. |
|
E.5.2 | 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).
|
1. De incidentie en HET beloop van donor-specifieke antistoffen in niertransplantatie patiënten met een immunologisch laag risico na één jaar na niertransplantatie. 2. Beschermende antistof responsen na pneumococcen vaccinatie in patiënten met TAC vs TAC/MMF. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From inclusion 4 years after kidney transplantation till six years after kidney transplantation. |
vanf inclusie 4 jaar na niertransplantatie tot zes jaar na niertransplantatie. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject undergoing the trial. |
Laatste bezoek van de laatste patient. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |