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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

Page last updated: August 20, 2015

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