Cytomegalovirus Infections Clinical Trial
— IMPACTOfficial 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
| Verified date | February 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 326 |
| Est. completion date | August 31, 2009 |
| Est. primary completion date | August 31, 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | 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 |
| Belgium | Clin Univ de Bxl Hôpital Erasme | Bruxelles | |
| Belgium | UZ Gent | Gent | |
| Belgium | UZ Leuven Gasthuisberg | Leuven | |
| Brazil | Hospital das Clinicas - UNICAMP | Campinas | SP |
| Brazil | Hospital das Clinicas - UFRGS | Porto Alegre | RS |
| Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
| Brazil | Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio | Sao Paulo | SP |
| Brazil | Hospital Israelita Albert Einstein; Intensive Care Unit | Sao Paulo | SP |
| Canada | Uni of Alberta Hospital | Edmonton | Alberta |
| Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
| Canada | Mcgill University - Royal Victoria Hospital; Oncology | Montreal | Quebec |
| Canada | Toronto General Hospital | Toronto | Ontario |
| France | 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 | Vandoeuvre-les-nancy | |
| Germany | Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin | Berlin | |
| Germany | Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie | 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 | Hannover | |
| Germany | Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I | Lübeck | |
| Germany | Klinikum der Universitaet Regensburg; Nephrologie | Regensburg | |
| Italy | Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto | Bari | Puglia |
| Italy | ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi | Milano | Lombardia |
| Italy | Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive | Padova | Veneto |
| Italy | POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo | Roma | Lazio |
| New Zealand | Auckland City Hospital; Renal Unit, Level 15 | Auckland | |
| Poland | Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj | Krakow | |
| Poland | Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii | Warszawa | |
| Poland | Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej | Wroclaw | |
| Romania | Institutul de Urologie Si Transplant Renal Fundeni | Bucharest | |
| Romania | Institutul de Urologie Si Transplant Renal Cluj Napoca | Cluj Napoca | |
| Spain | Hospital de Cruces; Servicio de Enfermedades Infecciosas | Barakaldo | Vizcaya |
| Spain | Hospital Universitari Vall d'Hebron; Servicio de Nefrologia | Barcelona | |
| Spain | Hospital Universitari de Bellvitge; Servicio de Nefrologia | Hospitalet de Llobregat | 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 | |
| United Kingdom | 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 States | Uni of Michigan Medical Center | Ann Arbor | Michigan |
| United States | Uni of Alabama At Birmingham | Birmingham | Alabama |
| United States | New England Medical Center; Division of Transplant Surgery | Boston | Massachusetts |
| United States | Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program | Chicago | Illinois |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Indiana Uni Medical Center; Surgery & Microbiology/Immunology | Indianapolis | Indiana |
| United States | St. Barnabas Medical Center | Livingston | New Jersey |
| United States | National Institute of Transplantation | Los Angeles | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | Uni of Minnesota Medical Center; Dept of Surgery | Minneapolis | Minnesota |
| United States | Vanderbilt Uni ; Divison of Nephrology | Nashville | Tennessee |
| United States | Robert Wood Johnson Uni Hospital; Anesthesia | New Brunswick | New Jersey |
| United States | Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery | Philadelphia | Pennsylvania |
| United States | Uni of Pennslyvania Medical Center | Philadelphia | Pennsylvania |
| United States | Oregon Health Sciences Uni ; Division of Nephrology | Portland | Oregon |
| 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 | 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 | Uni of Washington Medical Center; Division of Allergy & Infectious Diseases | Seattle | Washington |
| United States | Lifelink Healthcare Inst. | Tampa | Florida |
| United States | Wake Forest Uni School of Medicine; Section on Infectious Diseases | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, New Zealand, Poland, Romania, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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