The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus
Intervention: CMV Immune globulin (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s): John Pirsch, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
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.
Clinical Details
Official title: The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CMV viral load
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Wisconsin, Madison, Wisconsin 53792, United States
Additional Information
Starting date: January 2000
Last updated: July 25, 2012
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