Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.


Clinical Trial Description

Multidrug immunosuppression regimens have synergistic effects which allow the use of lower doses of individual agents. These regimens generally include calcineurin inhibitors (CNIs: cyclosporine or tacrolimus), mammalian target of rapamycin (mTOR) inhibitors (everolimus or sirolimus), and corticosteroids. CNIs and mTOR inhibitors are substrates for cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp); in addition, cyclosporine is a inhibitor of CYP3A4 and P-gp. Therefore, concomitant administration of those drugs may alter their serum levels.

It is remained to be evaluated whether the pharmacokinetics or clinical efficacy of tacrolimus will be affected when the regimens contain everolimus in clinical practice and the effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs. Mycophenolate mofetil (MMF) has no effect on pharmacokinetics of tacrolimus; therefore, MMF is used as a control to understand the effects of everolimus on pharmacokinetics of tacrolimus in patients receiving de novo kidney transplants. The effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs was also assessed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02077556
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase Phase 4
Start date April 2014
Completion date January 15, 2019

See also
  Status Clinical Trial Phase
Completed NCT03789032 - Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat Phase 1
Completed NCT03706222 - Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan
Completed NCT02191358 - YouScript IMPACT Registry N/A
Completed NCT02485028 - Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg Phase 1
Completed NCT01896557 - Ranitidin Versus Omeprazole in Patients Taking Clopidogrel Phase 4
Completed NCT03011463 - Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1 Phase 1
Completed NCT02485041 - Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 100mg Phase 1
Completed NCT01477411 - A Drug-Drug Interaction Study of Digoxin and PA21 Phase 1
Completed NCT01477424 - A Drug-Drug Interaction Study of Warfarin and PA21 Phase 1
Completed NCT05558150 - Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac Phase 1
Completed NCT03493698 - A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects Phase 1
Completed NCT03126578 - Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam Phase 1
Completed NCT01369186 - Drug Drug Interactions of Aspirin and P2Y12-inhibitors Phase 4
Completed NCT02378220 - Pharmacogenetic Testing Among Home Health Patients N/A
Completed NCT01324752 - A Drug-Drug Interaction Study of Losartan and PA21 Phase 1
Completed NCT02500667 - A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects Phase 1
Completed NCT03801733 - Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin Phase 1
Completed NCT03801746 - Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin Phase 1
Completed NCT03801759 - Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide Phase 1
Completed NCT01736371 - Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion. N/A