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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510486-10-00
Enrollment
100
Registered
2024-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation

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

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Association between microbiome diversity measures and AUC0-tau and Cmax of mycophenolate and metabolites.

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026