Kidney transplantation MedDRA version: 20.0 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Prograf
Pharmaceutical Form: Capsule, hard
Trade Name: CellCept
Pharmaceutical Form: Tablet
Sponsors
Oslo University Hospital - Rikshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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. ? Adult patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: ? Pregnant or lactating female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the association between microbiome diversity and 12-hour mycophenolate pharmacokinetics;Secondary Objective: -association between microbiome diversity and 12-hour Tac PK -effects of MMF treatment on gut microbiome changes in treatment naïve patients and associated MPA 12-hour PK changes. -effects of Tac treatment on gut microbiome changes in treatment naïve patients and associated Tac 12-hour PK changes. -indirect association between microbiome diversity and immunosuppressant molecular pharmacodynamics (PD biomarkers). -compare gut microbiome diversity after kidney transplantation in Norwegian and US patients. -investigate if TTV is a clinical useful “immunometer”, i.e. reflect overall immunosuppression of the recipient. -investigate whether immunosuppressant molecular pharmacodynamics (cytokine responses, intracellular drug and drug target levels and down-stream mediators) can be predictive for rejection and adverse effects. -integrate the updated knowledge on MPA and Tac PK following renal transplantation in a combined population pharmacokinetic model for individualized dosing.;Primary end point(s): Association between microbiome diversity measures and AUC0-tau and Cmax of mycophenolate and metabolites;Timepoint(s) of evaluation of this end point: Three to eight weeks and one year after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Association between microbiome diversity measures and absolute F, AUC0-tau and Cmax of tacrolimus and metabolites. 2. Changes in microbiome diversity measures and mycophenolate (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of mycophenolate mofetil treatment. 3. Changes in microbiome diversity measures and tacrolimus (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of tacrolimus treatment. 4. Association between microbiome diversity measures and immunosuppressant molecular pharmacodynamics (PD markers), indirectly linked through pharmacokinetics. 5. Descriptive comparison of microbiome diversity measures between the two populations. 6. Associations between TTV viral load and immunosuppressive drug systemic exposure, acute rejection episodes, protocol biopsy scores and other opportunistic infections, e.g. CMV and BK DNAemia and incidence of bacterial infections. 7. Diagnostic sensitivity and specificity for immunosuppressant pharmacodynamic biomarkers as predictors for rejection and adverse effects. 8. Relative predictive error (PE%) and root mean squared error (RMSE%) of the developed pharmacokinetic model.;Timepoint(s) of evaluation of this end point: Three to eight weeks and one year after transplantation | — |
Countries
Norway
Contacts
Public ContactKarsten Midtvedt
Oslo University Hospital - Rikshospitalet
Outcome results
None listed