Predicting the impact of the gut microbiome on immunosuppressive drug metabolism in kidney transplant patients
Recruiting
- Conditions
- Kidney Transplantation
- Registration Number
- DRKS00023398
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
(i) Recipients of a living kidney donor transplant of any age or
patients on the waiting list for deceased kidney donor transplantation of any age
(ii) Treatment with tacrolimus as part of their immunosuppressive regimen during at least two time periods within the study period
(iii) Written informed consent from adult patients, who are able to give consent
(iv) Patient consent and written informed consent from caregivers from underage patient
Exclusion Criteria
(i) Patients with preexisting liver disease defined as cirrhosis, systemic inflammation (infectious, chemical or autoimmune) or hepatic tumors
(ii) Non- Caucasian patients
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this exploratory study is to identify microbiome-based biomarkers with the potential to predict the individual starting dose of immunosuppressants with narrow therapeutic index after kidney transplantation.
- Secondary Outcome Measures
Name Time Method Characterization of the pre-transplant microbiome and its longitudinal evolution over the course of kidney transplantation.<br>(ii) Analysis of the potential association of treatment failures (graft loss, allograft rejection, change of immunosuppressive drug regimen and hospitalization) with microbiome characteristics in order to identify predictive microbiome-based biomarkers for treatment failure.<br>(iii) To evaluate whether the microbiome affects prolonged-release tacrolimus differently.