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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

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: July 25, 2012
Last verified: July 2012
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.

Condition Intervention
Drug: CMV Immune globulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • CMV viral load [ Time Frame: 12 months ]

Enrollment: 28
Study Start Date: January 2000
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cytogam in addition to standard of care (IV ganciclovir therapy)
Drug: CMV Immune globulin
CMV IvIg 150mg/kg x 6 doses
No Intervention: 2
Receive standard of care therapy (IV ganciclovir)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00214240

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: John Pirsch, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214240     History of Changes
Other Study ID Numbers: 1999-492
Study First Received: September 13, 2005
Last Updated: July 25, 2012

Additional relevant MeSH terms:
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents processed this record on May 25, 2017