Pharmacokinetics of Mmf and Valganciclovir

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00189150
First received: September 12, 2005
Last updated: September 19, 2005
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Kidney Transplant Recipient
Heart Transplant Recipient
Drug: Mycophenolate mofetil
Drug: Valganciclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Mycophenolate Mofetil Alone and in Combination With Valganciclovir in Renal and Heart Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To determine whether the effects of valganciclovir on mycophenolate mofetil pharmacokinetic parameters are deferent between renal and heart transplant recipients

Estimated Enrollment: 24
Study Start Date: April 2005
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 metabolized to active forms, mycophenolic acid (MPA) and gancoclovir (GCV) respectively. Both MPA and GCV are eliminated through kidney and renal excretion, but there is no data on how MPA pharmacokinetic parameters are affected by GCV at steady state condition. Both MPA and GCV can cause neutropenia and although unsubstantiated, some clinicians have observed an increased occurrence of neutropenia when these agents are used in combination. In the presence of neutropenia, practitioners are often challenged when making decisions regarding whether the dosage of one or both agents should be reduced. It would be useful to know whether the neutropenia is due to increased drug concentration or whether it is due to direct effects of these agents on the bone marrow.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189150

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jeong M Park, MS, PharmD    734-647-4711    jeongp@med.umich.edu   
Principal Investigator: Jeong M Park, MS, PharmD         
Sponsors and Collaborators
University of Michigan
Hoffmann-La Roche
Investigators
Principal Investigator: Jeong M Park, MS, PharmD University of Michigan Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189150     History of Changes
Other Study ID Numbers: Val060
Study First Received: September 12, 2005
Last Updated: September 19, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Valganciclovir
Mycophenolate Mofetil
Pharmacokinetic
Interaction
MPA

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Valganciclovir
Ganciclovir
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014