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The Effects of Microbiota Composition on Immunosuppression Protocols in Transplantation

NCT04360031 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-04-24

No results posted yet for this study

Summary

Solid organ transplantation is the treatment of choice for patients suffering from end-stage organ disease, including for chronic kidney failure. The implementation of effective immunosuppressive therapies has already significantly improved the prognosis for graft survival. However, these therapies are often associated with considerable inter- and intra-individual variability both in terms of response or in terms of pharmacokinetics. Innovative approaches must be considered, such as studying the involvement of intestinal microbiota in the pharmacology of these drugs.

The general aim of the study is therefore to relate the variabilities observed in the pharmacology (mainly pharmacokinetics) of immunosuppressive drugs used in renal transplantation (tacrolimus and mycophenolate mofetil) and the composition of the intestinal microbiota of renal transplant patients.

Conditions

  • Kidney Transplant; Complications
  • Immunosuppression
  • Transplant Failure

Interventions

DRUG

Tacrolimus

Tacrolimus and Mycophenolate Mofetil are given in accordance with patient's current regimen

Sponsors & Collaborators

  • Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Vincent Haufroid, MD · Université Catholique de Louvain

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360031 on ClinicalTrials.gov