Mycophenolate mofetil for Kidney transplantation

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Pregnant or lactating female patients."}

Primary endpoints

• {"endpoint_text":"- Association between microbiome diversity measures and AUC0-tau and Cmax of mycophenolate and metabolites.","definition_or_measurement_approach":"Association between microbiome diversity measures and pharmacokinetic parameters AUC0-tau and Cmax of mycophenolate and its metabolites (PK measurements of mycophenolate AUC0-tau and Cmax; microbiome diversity metrics)."}

Secondary endpoints

• {"endpoint_text":"- Association between microbiome diversity measures and absolute F, AUC0-tau and Cmax of tacrolimus and metabolites.","definition_or_measurement_approach":"Association between microbiome diversity measures and tacrolimus PK parameters (absolute bioavailability F, AUC0-tau, Cmax) and metabolites."}
• {"endpoint_text":"- Changes in microbiome diversity measures and mycophenolate (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of mycophenolate mofetil treatment.","definition_or_measurement_approach":"Measure changes in microbiome diversity and mycophenolate PK parameters (AUC0-tau, Cmax, Tmax, elimination rate constant kel) after one week of mycophenolate mofetil treatment."}
• {"endpoint_text":"- Changes in microbiome diversity measures and tacrolimus (and metabolite) AUC0-tau, Cmax, Tmax and kel with one week of tacrolimus treatment","definition_or_measurement_approach":"Measure changes in microbiome diversity and tacrolimus PK parameters (AUC0-tau, Cmax, Tmax, kel) after one week of tacrolimus treatment."}
• {"endpoint_text":"- To investigate the indirect association between microbiome diversity and immunosuppressant molecular pharmacodynamics (PD biomarkers).","definition_or_measurement_approach":"Assessment of associations between microbiome diversity metrics and PD biomarkers related to immunosuppressant effect (molecular PD biomarkers)."}
• {"endpoint_text":"- Descriptive comparison of microbiome diversity measures between the two populations.","definition_or_measurement_approach":"Descriptive comparison of microbiome diversity measures between Norwegian and US patient populations."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assess correlations between Torque teno virus (TTV) viral load and drug exposure, clinical outcomes (acute rejection, biopsy scores) and opportunistic infections (CMV, BK DNAemia) and bacterial infection incidence."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Evaluation of PD measures (cytokine responses, intracellular drug/target levels, downstream mediators) as predictors of rejection and adverse effects."}
• {"endpoint_text":"- Relative predictive error (PE%) and root mean squared error (RMSE%) of the developed pharmacokinetic model.","definition_or_measurement_approach":"Model performance metrics (PE%, RMSE%) for the developed pharmacokinetic model."}
• {"endpoint_text":"- Relative predictive error (PE%) and root mean squared error (RMSE%) of the developed PKPD model","definition_or_measurement_approach":"Model performance metrics (PE%, RMSE%) for the developed PKPD model."}

Norway

Earliest CTIS Part Ii Submission Date

30-04-2024

Latest Decision Or Authorization Date

22-05-2024

Processing Time Days

22

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway