IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 31, 2006 |
| End Date: | August 31, 2009 |
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients
This study will determine the relative efficacy and safety of up to 100 days Valcyte
prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of
CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study
treatment is 3-12 months and the target sample size is 100-500 individuals.
prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of
CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study
treatment is 3-12 months and the target sample size is 100-500 individuals.
Inclusion Criteria:
- ≥ 16 years of age
- CMV seronegative recipient of primary or secondary renal allograft from a living or
cadaveric seropositive donor
- Adequate hematological and renal function
- Patients and partners must agree to maintain effective birth control for 90 days
following cessation of study medication
Exclusion Criteria:
- CMV disease, or receipt of anti-CMV therapy within 30 days prior to screening
- Multi-organ transplant recipient
- Hepatitis B, hepatitis C or HIV positive
- Women who are pregnant or lactating
We found this trial at
24
sites
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50 Missenden Road
Camperdown, New South Wales 2050
Camperdown, New South Wales 2050
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1653 W Congress Pkwy
Chicago, Illinois 60612
Chicago, Illinois 60612
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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340 West 10th Street
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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420 Delaware Street Southeast
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97201
Portland, Oregon 97201
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7703 Floyd Curl Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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1959 Northeast Pacific Street
Seattle, Washington 98195
Seattle, Washington 98195
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1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
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