Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Kidney transplant recipients of living- and deceased donor grafts and treated with both
mycophenolate mofetil (MMF) and tacrolimus (Tac) will be included. A 12-hour pharmacokinetic
(PK) investigation of both mycophenolate (MPA) and Tac will be performed in pharmacokinetic
steady state conditions between 3 to 8 weeks and one year after transplantation. Feces
samples will be collected before (if possible), 1 week after transplantation and at the day
of the 12-hour PK investigations. Data on dietary intake and physical activity will be
obtained in association with the feces sampling in all patients. Patients will be invited to
a follow-up visit one year after transplantation where the 12-hour PK investigation, feces
sampling, dietary and activity data collection is repeated. Standard follow-up data after
renal transplantations, such as acute rejection episodes, infections, renal function, post
transplant diabetes mellitus (PTDM), protocol biopsies, adherence to immunosuppressive drugs,
graft loss and death will be collected for all patients up to 5 years after transplantation
according to standard schedule at the transplant center.
A subgroup of kidney transplant recipients scheduled for living donor transplantation will be
included before transplantation for pre-transplant investigations in addition to the
investigations after transplantation. These patients will be randomized to either receive one
week of treatment with MMF or Tac before transplantation. Feces samples and a 12-hour PK
investigation will be performed after one week of treatment (before transplantation).