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

University of Wisconsin (UW)

Status: Completed

Conditions: Cytomegalovirus

Treatments: Drug: CMV Immune globulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00214240

1999-492

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

Cytogam in addition to standard of care (IV ganciclovir therapy)

Treatment:

Drug: CMV Immune globulin

2

No Intervention group

Description:

Receive standard of care therapy (IV ganciclovir)