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.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214240
First received: September 13, 2005
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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
Cytomegalovirus
Drug: CMV Immune globulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214240

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214240     History of Changes
Other Study ID Numbers: 1999-492
Study First Received: September 13, 2005
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Pancrelipase
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014