IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
- Registration Number
- NCT00294515
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- ≥ 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valganciclovir up to 100 days Valganciclovir Valganciclovir for up to 100 days post kidney transplant Valganciclovir up to 200 days Valganciclovir Valganciclovir for up to 200 days post kidney transplant
- Primary Outcome Measures
Name Time Method Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant 12 months 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant 24 months 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.
Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant 6 months 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.
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant 9 months 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.
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant 18 months 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.
Trial Locations
- Locations (80)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Robert Wood Johnson Uni Hospital; Anesthesia
🇺🇸New Brunswick, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Hopital Lapeyronie; Nephrologie
🇫🇷Montpellier, France
Hospital Israelita Albert Einstein; Intensive Care Unit
🇧🇷Sao Paulo, SP, Brazil
Hopital Pellegrin; Departement Nephrologie
🇫🇷Bordeaux, France
Uni of Pennslyvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Auckland City Hospital; Renal Unit, Level 15
🇳🇿Auckland, New Zealand
Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio
🇧🇷Sao Paulo, SP, Brazil
Ch Pitie Salpetriere; Urologie
🇫🇷Paris, France
Clin Univ de Bxl Hôpital Erasme
🇧🇪Bruxelles, Belgium
Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse
🇩🇪Frankfurt, Germany
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
UZ Gent
🇧🇪Gent, Belgium
Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
🇩🇪Erlangen, Germany
Mcgill University - Royal Victoria Hospital; Oncology
🇨🇦Montreal, Quebec, Canada
POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
🇮🇹Roma, Lazio, Italy
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
🇫🇷Grenoble, France
Hopital Bretonneau; Nephrologie Transplantations
🇫🇷Tours, France
Uni of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
🇬🇧Bristol, United Kingdom
Hospital das Clinicas - UFRGS
🇧🇷Porto Alegre, RS, Brazil
Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
🇮🇹Bari, Puglia, Italy
Hospital General Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive
🇮🇹Padova, Veneto, Italy
Hospital de Cruces; Servicio de Enfermedades Infecciosas
🇪🇸Barakaldo, Vizcaya, Spain
Western Infirmary; Division of Cardiovascular and Medical Sciences
🇬🇧Glasgow, United Kingdom
Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur
🇩🇪Hannover, Germany
Klinikum der Universitaet Regensburg; Nephrologie
🇩🇪Regensburg, Germany
Nottingham City Hospital; Transplant Unit
🇬🇧Nottingham, United Kingdom
Royal Liverpool Uni Hospital; Renal Dept
🇬🇧Liverpool, United Kingdom
Royal London Hospital; Renal Unit
🇬🇧London, United Kingdom
Antrim Hospital; Renal Dept
🇬🇧Antrim, United Kingdom
Churchill Hospital; Oxford Transplant Center Renal Transplant Unit
🇬🇧Oxford, United Kingdom
Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas
🇪🇸Madrid, Spain
Manchester Royal Infirmary; Renal Transplant Unit
🇬🇧Manchester, United Kingdom
Freeman Hospital; Nephrology
🇬🇧Newcastle Upon Tyne, United Kingdom
Uni of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Uni of California San Francisco; Transplant Services
🇺🇸San Francisco, California, United States
Uni of Minnesota Medical Center; Dept of Surgery
🇺🇸Minneapolis, Minnesota, United States
Ucsd Medical Center; Kidney Transplantation
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
🇺🇸Chicago, Illinois, United States
New England Medical Center; Division of Transplant Surgery
🇺🇸Boston, Massachusetts, United States
Indiana Uni Medical Center; Surgery & Microbiology/Immunology
🇺🇸Indianapolis, Indiana, United States
Vanderbilt Uni ; Divison of Nephrology
🇺🇸Nashville, Tennessee, United States
Texas Transplant Inst.
🇺🇸San Antonio, Texas, United States
Uni of Texas Health Science Center At San Antonio; Organ Transplant Program
🇺🇸San Antonio, Texas, United States
Uni of Washington Medical Center; Division of Allergy & Infectious Diseases
🇺🇸Seattle, Washington, United States
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
🇮🇹Milano, Lombardia, Italy
Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj
🇵🇱Krakow, Poland
Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii
🇵🇱Warszawa, Poland
Institutul de Urologie Si Transplant Renal Cluj Napoca
🇷🇴Cluj Napoca, Romania
Institutul de Urologie Si Transplant Renal Fundeni
🇷🇴Bucharest, Romania
CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation
🇫🇷Toulouse, France
Hopitaux De Brabois; Nephrologie
🇫🇷Vandoeuvre-les-nancy, France
Royal Melbourne Hospital; Nephrology
🇦🇺Parkville, Victoria, Australia
Monash Medical Centre; Renal Transplant Unit
🇦🇺Clayton, Victoria, Australia
National Institute of Transplantation
🇺🇸Los Angeles, California, United States
Lifelink Healthcare Inst.
🇺🇸Tampa, Florida, United States
Uni of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Wake Forest Uni School of Medicine; Section on Infectious Diseases
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health Sciences Uni ; Division of Nephrology
🇺🇸Portland, Oregon, United States
Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery
🇺🇸Philadelphia, Pennsylvania, United States
Hospital das Clinicas - UNICAMP
🇧🇷Campinas, SP, Brazil
Royal Prince Alfred Hospital; Renal Transplant Unit
🇦🇺Camperdown, New South Wales, Australia
Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
🇫🇷Nantes, France
Hopital Civil; Clinique Medicale
🇫🇷Strasbourg, France
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
🇩🇪Berlin, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I
🇩🇪Lübeck, Germany
Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej
🇵🇱Wroclaw, Poland
Hospital Universitari de Bellvitge; Servicio de Nefrologia
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Dr. Peset; Servicio de Nefrologia
🇪🇸Valencia, Spain
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
🇪🇸Barcelona, Spain
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin
🇩🇪Berlin, Germany
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada