Status:
COMPLETED
Pharmacokinetics of Mmf and Valganciclovir
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Kidney Transplant Recipient
Heart Transplant Recipient
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine whether a clinically significant PK drug interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under steady state ...
Detailed Description
Mycophenolate mofetil (immunosuppressant, MMF) and valganciclovir (antiviral, VGCV) are commonly administered together in transplant patients. Following oral administration, both MMF and VGCV are meta...
Eligibility Criteria
Inclusion
- The subject must be able to give informed consent for the study. Stable renal or cardiac transplant patients age 18 years and older. Patients must not have had an acute rejection episode within the previous 30 days of the 1st PK study.
- Renal transplant patients with serum creatinine \< 2 mg/dL and with change in serum creatinine \< 25% within the 2 weeks prior to the 1st PK study.
- Renal and cardiac transplant patients receiving VGCV for prophylaxis of CMV while concomitantly receiving MMF.
- Stable MMF dose: the dose of MMF must not have been adjusted within 1 week of the 1st PK study and must be the same during the 2nd PK study Stable renal function during the study period (change in serum creatinine \< 25%)
Exclusion
- Patients who are not prescribed MMF maintenance therapy or are receiving Myfortic.
- Patients who do not require VGCV prophylaxis (CMV negative recipients of CMV negative donor organs).
- Patients who have their MMF doses adjusted either \< 1 week before the 1st scheduled PK study or anytime during the study period.
- Patients whose serum creatinine changes by \> 25% within 2 weeks prior to study initiation.
- Patients whose hematocrit \< 28%. Patients who received other organ transplants in addition to a kidney or heart. Patients who are pregnant or breast-feeding. Patients prescribed bile acids, bile acid sequestrants, potassium binding resins, or magnesium/aluminum-containing antacids.
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Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00189150
Start Date
April 1 2005
End Date
August 1 2007
Last Update
May 25 2016
Active Locations (1)
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1
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109