IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
NCT ID: NCT00294515
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2006-03-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Valganciclovir up to 100 days
Valganciclovir for up to 100 days post kidney transplant
Valganciclovir
900 mg orally daily for up to 100 days
Valganciclovir up to 200 days
Valganciclovir for up to 200 days post kidney transplant
Valganciclovir
900 mg orally daily for up to 200 days
Interventions
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Valganciclovir
900 mg orally daily for up to 100 days
Valganciclovir
900 mg orally daily for up to 200 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Multi-organ transplant recipient
* Hepatitis B, hepatitis C or HIV positive
* Women who are pregnant or lactating
16 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Uni of Alabama At Birmingham
Birmingham, Alabama, United States
National Institute of Transplantation
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Ucsd Medical Center; Kidney Transplantation
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Uni of California San Francisco; Transplant Services
San Francisco, California, United States
Lifelink Healthcare Inst.
Tampa, Florida, United States
Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
Chicago, Illinois, United States
Indiana Uni Medical Center; Surgery & Microbiology/Immunology
Indianapolis, Indiana, United States
New England Medical Center; Division of Transplant Surgery
Boston, Massachusetts, United States
Uni of Michigan Medical Center
Ann Arbor, Michigan, United States
Uni of Minnesota Medical Center; Dept of Surgery
Minneapolis, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Robert Wood Johnson Uni Hospital; Anesthesia
New Brunswick, 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
Uni of Pennslyvania Medical Center
Philadelphia, Pennsylvania, 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
Royal Prince Alfred Hospital; Renal Transplant Unit
Camperdown, New South Wales, Australia
Monash Medical Centre; Renal Transplant Unit
Clayton, Victoria, Australia
Royal Melbourne Hospital; Nephrology
Parkville, Victoria, Australia
Clin Univ de Bxl Hôpital Erasme
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, Brazil
Hospital Israelita Albert Einstein; Intensive Care Unit
São Paulo, São Paulo, Brazil
Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio
São Paulo, São Paulo, Brazil
Uni of Alberta Hospital
Edmonton, Alberta, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada
Hopital Pellegrin; Departement Nephrologie
Bordeaux, , France
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, , France
Hopital Lapeyronie; Nephrologie
Montpellier, , France
Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
Nantes, , France
Ch Pitie Salpetriere; Urologie
Paris, , France
Hopital Civil; Clinique Medicale
Strasbourg, , France
CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation
Toulouse, , France
Hopital Bretonneau; Nephrologie Transplantations
Tours, , France
Hopitaux De Brabois; Nephrologie
Vandœuvre-lès-Nancy, , France
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, , Germany
Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin
Berlin, , Germany
Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
Erlangen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse
Frankfurt, , Germany
Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur
Hanover, , Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I
Lübeck, , Germany
Klinikum der Universitaet Regensburg; Nephrologie
Regensburg, , Germany
Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
Bari, Apulia, Italy
POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
Rome, Lazio, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
Milan, Lombardy, Italy
Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive
Padua, Veneto, Italy
Auckland City Hospital; Renal Unit, Level 15
Auckland, , New Zealand
Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj
Krakow, , Poland
Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii
Warsaw, , Poland
Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej
Wroclaw, , Poland
Institutul de Urologie Si Transplant Renal Fundeni
Bucharest, , Romania
Institutul de Urologie Si Transplant Renal Cluj Napoca
Cluj-Napoca, , Romania
Hospital Universitari de Bellvitge; Servicio de Nefrologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Cruces; Servicio de Enfermedades Infecciosas
Barakaldo, Vizcaya, Spain
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
Barcelona, , Spain
Hospital General Univ. Gregorio Maranon
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas
Madrid, , Spain
Hospital Universitario Dr. Peset; Servicio de Nefrologia
Valencia, , Spain
Antrim Hospital; Renal Dept
Antrim, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
Bristol, , United Kingdom
Western Infirmary; Division of Cardiovascular and Medical Sciences
Glasgow, , United Kingdom
Royal Liverpool Uni Hospital; Renal Dept
Liverpool, , United Kingdom
Royal London Hospital; Renal Unit
London, , United Kingdom
Manchester Royal Infirmary; Renal Transplant Unit
Manchester, , United Kingdom
Freeman Hospital; Nephrology
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital; Transplant Unit
Nottingham, , United Kingdom
Churchill Hospital; Oxford Transplant Center Renal Transplant Unit
Oxford, , United Kingdom
Countries
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References
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Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
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.
Other Identifiers
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NT18435
Identifier Type: -
Identifier Source: org_study_id
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