IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Cytomegalovirus Infections

Intervention / Treatment
-----------------
* Drug: Valganciclovir
* Drug: Valganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valganciclovir up to 100 days<br>Valganciclovir for up to 100 days post kidney transplant | Drug: Valganciclovir<br>* 900 mg orally daily for up to 100 days<br>* Other names: Valcyte;|
| Active Comparator: Valganciclovir up to 200 days<br>Valganciclovir for up to 200 days post kidney transplant | Drug: Valganciclovir<br>* 900 mg orally daily for up to 200 days<br>* Other names: Valcyte;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant | Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant. | 12 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant | Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant. | 6 months post-transplant | 
| Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant | Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant. | 9 months post-transplant | 
| Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant | Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant. | 18 months post-transplant | 
| Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant | Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant. | 24 months post-transplant |