Kidney transplantation
Conditions
Brief summary
Association between microbiome diversity measures and AUC0-tau and Cmax of mycophenolate and metabolites.
Detailed description
Association between microbiome diversity measures and absolute F, AUC0-tau and Cmax of tacrolimus and metabolites., Changes in microbiome diversity measures and mycophenolate (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of mycophenolate mofetil treatment., Changes in microbiome diversity measures and tacrolimus (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of tacrolimus treatment, To investigate the indirect association between microbiome diversity and immunosuppressant molecular pharmacodynamics (PD biomarkers)., Descriptive comparison of microbiome diversity measures between the two populations., 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., 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., Relative predictive error (PE%) and root mean squared error (RMSE%) of the developed pharmacokinetic model., Relative predictive error (PE%) and root mean squared error (RMSE%) of the developed PKPD model
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between microbiome diversity measures and AUC0-tau and Cmax of mycophenolate and metabolites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between microbiome diversity measures and absolute F, AUC0-tau and Cmax of tacrolimus and metabolites., Changes in microbiome diversity measures and mycophenolate (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of mycophenolate mofetil treatment., Changes in microbiome diversity measures and tacrolimus (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of tacrolimus treatment, To investigate the indirect association between microbiome diversity and immunosuppressant molecular pharmacodynamics (PD biomarkers)., Descriptive comparison of microbiome diversity measures between the two populations., 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., Investigate whether immunosuppressant molecular pharmacodynamics (cytokine responses, intracellular drug and drug target levels and do | — |
Countries
Norway