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 1
- Conditions
- kidney transplantation vaccination responsesTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2019-001854-24-NL
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 76
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
A potential subject who is unable to give written informed consent will be excluded from participation in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method