Authorised Therapeutic use (Phase IV) Kidney transplantation

Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects

EU CTIS ID: 2023-510486-10-00

What this study is testing

To investigate the association between microbiome diversity and 12-hour mycophenolate pharmacokinetics

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • De novo, standard risk kidney (only) transplant recipients.
  • Patients scheduled to receive tacrolimus and mycophenolate mofetil as part of their immunosuppressive therapy following transplantation (clinical decision not influenced by this study).
  • First kidney transplant only.
  • Recipients of kidney from deceased or living adult donor
  • ABO-compatible transplantation
  • PRA ≤20%

You likely can't join if

  • Pregnant or lactating female patients.
See the full eligibility criteria
Who can join
  • De novo, standard risk kidney (only) transplant recipients.
  • Patients scheduled to receive tacrolimus and mycophenolate mofetil as part of their immunosuppressive therapy following transplantation (clinical decision not influenced by this study).
  • First kidney transplant only.
  • Recipients of kidney from deceased or living adult donor
  • ABO-compatible transplantation
  • PRA ≤20%
  • DSA negative
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
What rules you out
  • Pregnant or lactating female patients.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.