2026-527106-20-00招募中4 期
Influence of Antimicrobial Drugs on Mycophenolic acid and Tacrolimus Pharmacokinetics and the Gut Microbiome in Kidney Transplant Recipients (AXIS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- AUC0-12/0-24 and Cmax ratios of Tac with:without antimicrobial treatment
研究概览
简要总结
To investigate the effect of treatment with antimicrobial drugs on the PK of tacrolimus (Tac) and mycophenolate mofetil (MMF) in kidney transplant recipients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients on stable immunosuppressive therapy for the least two weeks needing treatment (>5 days) with antimicrobial therapy such as ciprofloxacin, meropenem and trimethoprim-sulfamethoxazole but could include other antimicrobial drugs as well.
- •Immunosuppressive drug regimen containing Prograf® (tacrolimus twice daily) or Advagraf® (tacrolimus once daily) and/or CellCept®/Mycophenolate mofetil Accord® (mycophenolate mofetil twice daily).
- •Above 18 years of age.
- •Able to comply with the medical treatment on their own
- •Signed informed consent
排除标准
- •Recent (1 month) rejection episode of the kidney graft treated with methylprednisolone
- •Recent (less than 12 weeks) since previous infection period treated with antibiotics
- •Patients admitted to the ICU due to the infection
- •Changes in concomitant treatment with drugs known to interact with Tac or MMF between PK visits, such as (but not limited to): diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, voriconazole, ritonavir, cholestyramine, rifampicin.
- •Severe diarrhea at time of PK investigation and/or persistent abnormal stool consistency during the week preceding the PK investigations
- •Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (see section 6.7 for details).
研究组 & 干预措施
CellCept 500 mg film-coated tablets
Test
干预措施: CellCept 500 mg film-coated tablets (Drug)
Advagraf 1 mg prolonged-release hard capsules
Test
干预措施: Advagraf 1 mg prolonged-release hard capsules (Drug)
PROGRAF 1 mg capsule
Test
干预措施: PROGRAF 1 mg capsule (Drug)
Mycophenolate mofetil Accord 500 mg filmdragerade tabletter
Test
干预措施: Mycophenolate mofetil Accord 500 mg filmdragerade tabletter (Drug)
结局指标
主要结局
AUC0-12/0-24 and Cmax ratios of Tac with:without antimicrobial treatment
AUC0-12/0-24 and Cmax ratios of Tac with:without antimicrobial treatment
AUC0-12/0-24 and Cmax ratios of MPA with:without antimicrobial treatment
AUC0-12/0-24 and Cmax ratios of MPA with:without antimicrobial treatment
次要结局
- Tac and MPA pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F
- population pharmacokinetic model parameters
- genotype of relevant drug metabolizing enzymes and transporters
- taxonomic diversity in fecal metagenomes
- microbiome-derived ex vivo drug reactivation/conversion rates
- ARGs
研究者
Anders Åsberg
Scientific
Oslo Universitetssykehus HF
研究点 (1)
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