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IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients (IMPACT)

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ClinicalTrials.gov Identifier: NCT00294515
Recruitment Status : Completed
First Posted : February 22, 2006
Results First Posted : July 5, 2010
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: Valganciclovir Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2006
Actual Primary Completion Date : August 31, 2008
Actual Study Completion Date : August 31, 2009


Arm Intervention/treatment
Experimental: Valganciclovir up to 100 days
Valganciclovir for up to 100 days post kidney transplant
Drug: Valganciclovir
900 mg orally daily for up to 100 days
Other Name: Valcyte
Active Comparator: Valganciclovir up to 200 days
Valganciclovir for up to 200 days post kidney transplant
Drug: Valganciclovir
900 mg orally daily for up to 200 days
Other Name: Valcyte



Primary Outcome Measures :
  1. Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant [ Time Frame: 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 :
  1. Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant [ Time Frame: 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.

  2. Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant [ Time Frame: 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.

  3. Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant [ Time Frame: 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.

  4. Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant [ Time Frame: 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294515


  Hide Study Locations
Locations
United States, Alabama
Uni of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
National Institute of Transplantation
Los Angeles, California, United States, 90057
UCLA Medical Center
Los Angeles, California, United States, 90095
Ucsd Medical Center; Kidney Transplantation
San Diego, California, United States, 92103-8401
California Pacific Medical Center
San Francisco, California, United States, 94115
Uni of California San Francisco; Transplant Services
San Francisco, California, United States, 94143-0116
United States, Florida
Lifelink Healthcare Inst.
Tampa, Florida, United States, 33606
United States, Illinois
Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
Chicago, Illinois, United States, 60612-3824
United States, Indiana
Indiana Uni Medical Center; Surgery & Microbiology/Immunology
Indianapolis, Indiana, United States, 46202-5124
United States, Massachusetts
New England Medical Center; Division of Transplant Surgery
Boston, Massachusetts, United States, 02111
United States, Michigan
Uni of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0331
United States, Minnesota
Uni of Minnesota Medical Center; Dept of Surgery
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Robert Wood Johnson Uni Hospital; Anesthesia
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Wake Forest Uni School of Medicine; Section on Infectious Diseases
Winston-Salem, North Carolina, United States, 27157-1082
United States, Oregon
Oregon Health Sciences Uni ; Division of Nephrology
Portland, Oregon, United States, 97201
United States, Pennsylvania
Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery
Philadelphia, Pennsylvania, United States, 19102-1192
Uni of Pennslyvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Uni ; Divison of Nephrology
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Transplant Inst.
San Antonio, Texas, United States, 78229
Uni of Texas Health Science Center At San Antonio; Organ Transplant Program
San Antonio, Texas, United States, 78284
United States, Washington
Uni of Washington Medical Center; Division of Allergy & Infectious Diseases
Seattle, Washington, United States, 98195
Australia, New South Wales
Royal Prince Alfred Hospital; Renal Transplant Unit
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Monash Medical Centre; Renal Transplant Unit
Clayton, Victoria, Australia, 3186
Royal Melbourne Hospital; Nephrology
Parkville, Victoria, Australia, 3050
Belgium
Clin Univ de Bxl Hôpital Erasme
Bruxelles, Belgium, 1070
UZ Gent
Gent, Belgium, 9000
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90020-090
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-003
Hospital das Clinicas - UNICAMP
Campinas, SP, Brazil, 13083-888
Hospital Israelita Albert Einstein; Intensive Care Unit
Sao Paulo, SP, Brazil, 05651-901
Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio
Sao Paulo, SP, Brazil, 18048-900
Canada, Alberta
Uni of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2S2
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada, H3A 1A1
France
Hopital Pellegrin; Departement Nephrologie
Bordeaux, France, 33076
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, France, 38043
Hopital Lapeyronie; Nephrologie
Montpellier, France, 34295
Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
Nantes, France, 44035
Ch Pitie Salpetriere; Urologie
Paris, France, 75651
Hopital Civil; Clinique Medicale
Strasbourg, France, 67091
CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation
Toulouse, France, 31403
Hopital Bretonneau; Nephrologie Transplantations
Tours, France, 37044
Hopitaux De Brabois; Nephrologie
Vandoeuvre-les-nancy, France, 54511
Germany
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, Germany, 10117
Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin
Berlin, Germany, 13353
Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
Erlangen, Germany, 91054
Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse
Frankfurt, Germany, 60596
Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur
Hannover, Germany, 30625
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I
Lübeck, Germany, 23562
Klinikum der Universitaet Regensburg; Nephrologie
Regensburg, Germany, 93053
Italy
POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
Roma, Lazio, Italy, 00168
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
Milano, Lombardia, Italy, 20162
Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
Bari, Puglia, Italy, 70124
Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive
Padova, Veneto, Italy, 35128
New Zealand
Auckland City Hospital; Renal Unit, Level 15
Auckland, New Zealand, 1001
Poland
Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj
Krakow, Poland, 31-501
Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii
Warszawa, Poland, 02-006
Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej
Wroclaw, Poland, 50-417
Romania
Institutul de Urologie Si Transplant Renal Fundeni
Bucharest, Romania, 022328
Institutul de Urologie Si Transplant Renal Cluj Napoca
Cluj Napoca, Romania, 400006
Spain
Hospital Universitari de Bellvitge; Servicio de Nefrologia
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Cruces; Servicio de Enfermedades Infecciosas
Barakaldo, Vizcaya, Spain, 48903
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
Barcelona, Spain, 08035
Hospital General Univ. Gregorio Maranon
Madrid, Spain, 28009
Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas
Madrid, Spain, 28041
Hospital Universitario Dr. Peset; Servicio de Nefrologia
Valencia, Spain, 46017
United Kingdom
Antrim Hospital; Renal Dept
Antrim, United Kingdom, 2RL
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
Bristol, United Kingdom, BS10 5NB
Western Infirmary; Division of Cardiovascular and Medical Sciences
Glasgow, United Kingdom, G11 6NT
Royal Liverpool Uni Hospital; Renal Dept
Liverpool, United Kingdom, L7 8XP
Royal London Hospital; Renal Unit
London, United Kingdom, E1 1BB
Manchester Royal Infirmary; Renal Transplant Unit
Manchester, United Kingdom, M13 9WL
Freeman Hospital; Nephrology
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham City Hospital; Transplant Unit
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital; Oxford Transplant Center Renal Transplant Unit
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00294515     History of Changes
Other Study ID Numbers: NT18435
First Posted: February 22, 2006    Key Record Dates
Results First Posted: July 5, 2010
Last Update Posted: March 29, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents