Pharmacokinetics of Mmf and Valganciclovir

NCT00189150 | Completed Phase 4

• 1 other identifier: Val060
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 conditions) and VGCV in renal and cardiac transplant recipients. This study will provide clinically relevant information to the transplant community. It will more clearly delineate whether a clinically significant PK drug interaction exists between mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.

Conditions

Kidney Transplant Recipient; Heart Transplant Recipient

Keywords

Valganciclovir; Mycophenolate Mofetil; Pharmacokinetic; Interaction; MPA

Outcome Measures

Primary Outcomes (1)

• To determine whether a clinically significant pharmacokinetic drug interaction exists between mycophenolate mofetil and valganciclovir under steady state conditions in renal and heart transplant recipients

Secondary Outcomes (1)

• To determine whether the effects of valganciclovir on mycophenolate mofetil pharmacokinetic parameters are different between renal and heart transplant recipients

Interventions

Mycophenolate mofetil DRUG

Valganciclovir DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Mycophenolic Acid; Valganciclovir

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeong M Park, MS, PharmD

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

US (1)