Drug Interaction Potentiation Clinical Trial
Official title:
The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs
Verified date | July 2018 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.
Status | Completed |
Enrollment | 14 |
Est. completion date | January 15, 2019 |
Est. primary completion date | January 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion criteria: - De novo kidney transplants - 20 - 65 years old - aspartate aminotransferase/alanine aminotransferase within 2 times the upper limit of normal range Exclusion criteria: - Pregnancy - Tuberculosis - Hepatitis B or C carrier status - Human immunodeficiency virus-positive status - Retransplantation or multiorgan transplantation - History of rheumatoid arthritis - Use of drugs that might have enhanced or inhibited CYP3A4 or P-gp activity |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic profiles | Pharmacokinetic parameters include the maximum concentration, trough concentration, area under the whole-blood concentration-time curve between 0 and 12 hours, time to maximum concentration, volume of distribution at steady state, and clearance at steady state. | Post-operation day 8-10 | |
Secondary | Acute rejection | Within the first 2 weeks post-transplantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
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