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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

NCT ID: NCT00214240

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

CMV Immune globulin

Intervention Type DRUG

CMV IvIg 150mg/kg x 6 doses

2

Receive standard of care therapy (IV ganciclovir)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CMV Immune globulin

CMV IvIg 150mg/kg x 6 doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Pirsch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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1999-492

Identifier Type: -

Identifier Source: org_study_id