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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00294515




Registration number
NCT00294515
Ethics application status
Date submitted
21/02/2006
Date registered
22/02/2006
Date last updated
29/03/2018

Titles & IDs
Public title
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Scientific 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
Secondary ID [1] 0 0
NT18435
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Valganciclovir
Treatment: Drugs - Valganciclovir

Experimental: Valganciclovir up to 100 days - Valganciclovir for up to 100 days post kidney transplant

Active comparator: Valganciclovir up to 200 days - Valganciclovir for up to 200 days post kidney transplant


Treatment: Drugs: Valganciclovir
900 mg orally daily for up to 100 days

Treatment: Drugs: Valganciclovir
900 mg orally daily for up to 200 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
Timepoint [1] 0 0
12 months post-transplant
Secondary outcome [1] 0 0
Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
Timepoint [1] 0 0
6 months post-transplant
Secondary outcome [2] 0 0
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
Timepoint [2] 0 0
9 months post-transplant
Secondary outcome [3] 0 0
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
Timepoint [3] 0 0
18 months post-transplant
Secondary outcome [4] 0 0
Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
Timepoint [4] 0 0
24 months post-transplant

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2009
Sample size
Target
Accrual to date
Final
326
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital; Renal Transplant Unit - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre; Renal Transplant Unit - Clayton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital; Nephrology - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3186 - Clayton
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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California
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Florida
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Illinois
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Indiana
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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North Carolina
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Washington
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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RS
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Brazil
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SP
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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France
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Bordeaux
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France
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Grenoble
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France
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Montpellier
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Nantes
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Toulouse
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Tours
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Vandoeuvre-les-nancy
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Lübeck
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Germany
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Regensburg
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Veneto
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New Zealand
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Auckland
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Poland
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Krakow
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Spain
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Barcelona
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Spain
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Vizcaya
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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Antrim
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Birmingham
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Bristol
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Glasgow
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Liverpool
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London
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Manchester
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Newcastle Upon Tyne
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Nottingham
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00294515
Trial related presentations / publications
Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00294515