Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Cytomegalovirus (CMV) is the most common opportunistic viral pathogen in solid organ transplant receptors (SOTR). In Mexico, the experience using generic immunosuppressants have been demonstrated a wide variation in the pharmacokinetic parameters between generic and innovative formulation, resulting in a suboptimal absorption of the drug and reaching infratherapeutic trough levels in blood. In this study the investigators will compare the pharmacokinetic parameters of innovative and generic valganciclovir in renal transplant recipients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luis Eduardo Morales Buenrostro
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

• Signed consent form for the study

• Age between 18 and 70 years

• Kidney transplant recipients who are stable during their follow-up

• Kidney transplant recipients between day 31 and 90 post-transplant surgery

• Kidney transplant recipients under prophylaxis with valganciclovir

Exclusion Criteria:

• Participants who can not stay 12 hours at the hospital for taking the blood samples.

• Participants with an acute rejection event

• Participants with active cytomegalovirus disease

• Participants with measurements of pharmacokinetic parameters with a single formulation without comparator

• Participants that withdraw their informed consent