The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease

Cytomegalovirus Clinical Trial

Official title:

The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214240
• Other study ID #: 1999-492
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 25, 2012
• Start date: January 2000
• Est. completion date: April 2007

Study information

• Verified date: July 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus

Intervention

Drug:
• CMV Immune globulin
CMV IvIg 150mg/kg x 6 doses

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV viral load		12 months	No