drugset / Trial / NCT02221583

Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy

NCT02221583

RandomizedCrossoverDouble-blind

Summary

The purpose of this study is to evaluate how quickly and to what extent different immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune system is the body's defense against diseases. It also attacks "foreign" tissues such as a transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL), Prograf, and mycophenolate mofetil may be given to suppress the immune system following kidney transplantation and prevent rejection of a transplanted kidney. This study is being performed to determine if patients who undergo laparoscopic sleeve gastrectomy need different doses of immunosuppressant medications.

Timeline

Start
2014-05
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 1000 mg
Subject Tacrolimus Small molecule 4 mg
Subject Tacrolimus Small molecule 8 mg