Clinical trial NCT00294515: IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-02-22
Enrollment: 326
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
timeFrame: 12 months post-transplant
Secondary outcomes:
measure: Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
timeFrame: 6 months post-transplant
measure: Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
timeFrame: 9 months post-transplant
measure: Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
timeFrame: 18 months post-transplant
measure: Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
timeFrame: 24 months post-transplant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uni of Alabama At Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: National Institute of Transplantation
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: San Diego
country: United States
facility: Ucsd Medical Center; Kidney Transplantation
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Uni of California San Francisco; Transplant Services
state: California
city: Tampa
country: United States
facility: Lifelink Healthcare Inst.
state: Florida
city: Chicago
country: United States
facility: Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Uni Medical Center; Surgery & Microbiology/Immunology
state: Indiana
city: Boston
country: United States
facility: New England Medical Center; Division of Transplant Surgery
state: Massachusetts
city: Ann Arbor
country: United States
facility: Uni of Michigan Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Uni of Minnesota Medical Center; Dept of Surgery
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Livingston
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Uni Hospital; Anesthesia
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest Uni School of Medicine; Section on Infectious Diseases
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences Uni ; Division of Nephrology
state: Oregon
city: Philadelphia
country: United States
facility: Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery
state: Pennsylvania
city: Philadelphia
country: United States
facility: Uni of Pennslyvania Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Uni ; Divison of Nephrology
state: Tennessee
city: San Antonio
country: United States
facility: Texas Transplant Inst.
state: Texas
city: San Antonio
country: United States
facility: Uni of Texas Health Science Center At San Antonio; Organ Transplant Program
state: Texas
city: Seattle
country: United States
facility: Uni of Washington Medical Center; Division of Allergy & Infectious Diseases
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital; Renal Transplant Unit
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre; Renal Transplant Unit
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Nephrology
state: Victoria
city: Bruxelles
country: Belgium
facility: Clin Univ de Bxl Hôpital Erasme
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Campinas
country: Brazil
facility: Hospital das Clinicas - UNICAMP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein; Intensive Care Unit
state: SP
city: Sao Paulo
country: Brazil
facility: Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio
state: SP
city: Edmonton
country: Canada
facility: Uni of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Mcgill University - Royal Victoria Hospital; Oncology
state: Quebec
city: Bordeaux
country: France
facility: Hopital Pellegrin; Departement Nephrologie
city: Grenoble
country: France
facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
city: Montpellier
country: France
facility: Hopital Lapeyronie; Nephrologie
city: Nantes
country: France
facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
city: Paris
country: France
facility: Ch Pitie Salpetriere; Urologie
city: Strasbourg
country: France
facility: Hopital Civil; Clinique Medicale
city: Toulouse
country: France
facility: CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation
city: Tours
country: France
facility: Hopital Bretonneau; Nephrologie Transplantations
city: Vandoeuvre-les-nancy
country: France
facility: Hopitaux De Brabois; Nephrologie
city: Berlin
country: Germany
facility: Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
city: Berlin
country: Germany
facility: Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse
city: Hannover
country: Germany
facility: Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I
city: Regensburg
country: Germany
facility: Klinikum der Universitaet Regensburg; Nephrologie
city: Roma
country: Italy
facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
state: Lazio
city: Milano
country: Italy
facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
state: Lombardia
city: Bari
country: Italy
facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
state: Puglia
city: Padova
country: Italy
facility: Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive
state: Veneto
city: Auckland
country: New Zealand
facility: Auckland City Hospital; Renal Unit, Level 15
city: Krakow
country: Poland
facility: Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj
city: Warszawa
country: Poland
facility: Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii
city: Wroclaw
country: Poland
facility: Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej
city: Bucharest
country: Romania
facility: Institutul de Urologie Si Transplant Renal Fundeni
city: Cluj Napoca
country: Romania
facility: Institutul de Urologie Si Transplant Renal Cluj Napoca
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Enfermedades Infecciosas
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
city: Madrid
country: Spain
facility: Hospital General Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Nefrologia
city: Antrim
country: United Kingdom
facility: Antrim Hospital; Renal Dept
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bristol
country: United Kingdom
facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
city: Glasgow
country: United Kingdom
facility: Western Infirmary; Division of Cardiovascular and Medical Sciences
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Uni Hospital; Renal Dept
city: London
country: United Kingdom
facility: Royal London Hospital; Renal Unit
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary; Renal Transplant Unit
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital; Nephrology
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Transplant Unit
city: Oxford
country: United Kingdom
facility: Churchill Hospital; Oxford Transplant Center Renal Transplant Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: 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.