Predicting the impact of the gut microbiome on immunosuppressive drug metabolism in kidney transplant patients

Predicting the impact of the gut microbiome on immunosuppressive drug metabolism in kidney transplant patients - PRISMA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023398

Enrollment

130

Registered

2020-10-26

Start date

2021-01-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Kidney Transplantation

Interventions

Group 1: Model building cohort, living kidney donor recipient: Visit 1, pre immunosuppression (IS): CYP3A genotyping, Metabolomic analysis (feces, urine, blood), Metagenomic analysis (feces), Labora

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: (i) Patients with preexisting liver disease defined as cirrhosis, systemic inflammation (infectious, chemical or autoimmune) or hepatic tumors (ii) Non- Caucasian patients

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Characterization of the pre-transplant microbiome and its longitudinal evolution over the course of kidney transplantation. (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. (iii) To evaluate whether the microbiome affects prolonged-release tacrolimus differently.	—

Measure

Time frame

Characterization of the pre-transplant microbiome and its longitudinal evolution over the course of kidney transplantation. (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. (iii) To evaluate whether the microbiome affects prolonged-release tacrolimus differently.

—

Countries

Germany

Contacts

Public ContactMaral Baghai Arassi

Klinik Kinderheilkunde I, Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum Heidelberg Structural and Computational Biology, EMBL Heidelberg

maral.baghai@embl.de+49 (0) 6221 56 36688

Outcome results

None listed

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