The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
Not Applicable
Completed
- Conditions
- Cytomegalovirus
- Interventions
- Drug: CMV Immune globulin
- Registration Number
- NCT00214240
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection
- receiving no more than 48 hrs of therapy prior to study enrollment
Exclusion Criteria
- serum creatinine <2.2 at the time of enrollment
- no prior use of CMV IgG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CMV Immune globulin Cytogam in addition to standard of care (IV ganciclovir therapy)
- Primary Outcome Measures
Name Time Method CMV viral load 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States