Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

• Status: Completed
• Trial end date: 2019-01-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Everolimus; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sirolimus; Tacrolimus

Criteria

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