Status:
COMPLETED
Immunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Valganciclovir (VGCV) has recently been approved by the Food and Drug Administration (FDA) for the treatment and prevention of cytomegalovirus (CMV) retinitis in HIV patients. It is under review for t...
Detailed Description
Recruitment and screening of subjects will be performed between 4 and 8 weeks after transplantation at which time consent will be obtained. Per clinical standard of care at Indiana University, VGCV is...
Eligibility Criteria
Inclusion
- \>18 years of age
- Primary kidney transplant
- MMF included as part of baseline immunosuppression
- On valganciclovir for CMV prophylaxis. The dose will vary based on renal function but the standard dose is 900 mg per day
- No prior episodes of rejection
- On a stable dose of immunosuppressive medications -
Exclusion
- Previous or multiple transplant patients (e.g. second kidney or simultaneous kidney pancreas patient)
- Uncontrolled or recurrent infections.
- Psychiatric disorder -
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00198224
Start Date
January 1 2003
End Date
May 1 2005
Last Update
September 20 2005
Active Locations (2)
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1
Indiana University Hospital and Emerson Hall, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
2
University Hospital
Indianapolis, Indiana, United States, 46202