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

NCT00294515 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NT18435
• Study Type: interventional
• Target: 326
• Locations: 13 countries
• Sites: 80

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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant

  6 months post-transplant

• Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant

  9 months post-transplant

• Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant

  18 months post-transplant

• Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant

  24 months post-transplant

Study Arms (2)

Valganciclovir up to 100 days

EXPERIMENTAL

Valganciclovir for up to 100 days post kidney transplant

Drug: Valganciclovir

Valganciclovir up to 200 days

ACTIVE COMPARATOR

Valganciclovir for up to 200 days post kidney transplant

Drug: Valganciclovir

Interventions

Valganciclovir DRUG

900 mg orally daily for up to 100 days

Also known as: Valcyte

Valganciclovir up to 100 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (80)

Uni of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

National Institute of Transplantation

Los Angeles, California, 90057, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Ucsd Medical Center; Kidney Transplantation

San Diego, California, 92103-8401, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Uni of California San Francisco; Transplant Services

San Francisco, California, 94143-0116, United States

Location

Lifelink Healthcare Inst.

Tampa, Florida, 33606, United States

Location

Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program

Chicago, Illinois, 60612-3824, United States

Location

Indiana Uni Medical Center; Surgery & Microbiology/Immunology

Indianapolis, Indiana, 46202-5124, United States

Location

New England Medical Center; Division of Transplant Surgery

Boston, Massachusetts, 02111, United States

Location

Uni of Michigan Medical Center

Ann Arbor, Michigan, 48109-0331, United States

Location

Uni of Minnesota Medical Center; Dept of Surgery

Minneapolis, Minnesota, 55455, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Robert Wood Johnson Uni Hospital; Anesthesia

New Brunswick, New Jersey, 08901, United States

Location

Wake Forest Uni School of Medicine; Section on Infectious Diseases

Winston-Salem, North Carolina, 27157-1082, United States

Location

Oregon Health Sciences Uni ; Division of Nephrology

Portland, Oregon, 97201, United States

Location

Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery

Philadelphia, Pennsylvania, 19102-1192, United States

Location

Uni of Pennslyvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Uni ; Divison of Nephrology

Nashville, Tennessee, 37232, United States

Location

Texas Transplant Inst.

San Antonio, Texas, 78229, United States

Location

Uni of Texas Health Science Center At San Antonio; Organ Transplant Program

San Antonio, Texas, 78284, United States

Location

Uni of Washington Medical Center; Division of Allergy & Infectious Diseases

Seattle, Washington, 98195, United States

Location

Royal Prince Alfred Hospital; Renal Transplant Unit

Camperdown, New South Wales, 2050, Australia

Location

Monash Medical Centre; Renal Transplant Unit

Clayton, Victoria, 3186, Australia

Location

Royal Melbourne Hospital; Nephrology

Parkville, Victoria, 3050, Australia

Location

Clin Univ de Bxl Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, 13083-888, Brazil

Location

Hospital Israelita Albert Einstein; Intensive Care Unit

São Paulo, São Paulo, 05651-901, Brazil

Location

Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio

São Paulo, São Paulo, 18048-900, Brazil

Location

Uni of Alberta Hospital

Edmonton, Alberta, T6G 2S2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Mcgill University - Royal Victoria Hospital; Oncology

Montreal, Quebec, H3A 1A1, Canada

Location

Hopital Pellegrin; Departement Nephrologie

Bordeaux, 33076, France

Location

Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

Grenoble, 38043, France

Location

Hopital Lapeyronie; Nephrologie

Montpellier, 34295, France

Location

Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

Nantes, 44035, France

Location

Ch Pitie Salpetriere; Urologie

Paris, 75651, France

Location

Hopital Civil; Clinique Medicale

Strasbourg, 67091, France

Location

CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation

Toulouse, 31403, France

Location

Hopital Bretonneau; Nephrologie Transplantations

Tours, 37044, France

Location

Hopitaux De Brabois; Nephrologie

Vandœuvre-lès-Nancy, 54511, France

Location

Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie

Berlin, 10117, Germany

Location

Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin

Berlin, 13353, Germany

Location

Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

Erlangen, 91054, Germany

Location

Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse

Frankfurt, 60596, Germany

Location

Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur

Hanover, 30625, Germany

Location

Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I

Lübeck, 23562, Germany

Location

Klinikum der Universitaet Regensburg; Nephrologie

Regensburg, 93053, Germany

Location

Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

Bari, Apulia, 70124, Italy

Location

POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

Rome, Lazio, 00168, Italy

Location

ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

Milan, Lombardy, 20162, Italy

Location

Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive

Padua, Veneto, 35128, Italy

Location

Auckland City Hospital; Renal Unit, Level 15

Auckland, 1001, New Zealand

Location

Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj

Krakow, 31-501, Poland

Location

Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii

Warsaw, 02-006, Poland

Location

Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej

Wroclaw, 50-417, Poland

Location

Institutul de Urologie Si Transplant Renal Fundeni

Bucharest, 022328, Romania

Location

Institutul de Urologie Si Transplant Renal Cluj Napoca

Cluj-Napoca, 400006, Romania

Location

Hospital Universitari de Bellvitge; Servicio de Nefrologia

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital de Cruces; Servicio de Enfermedades Infecciosas

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

Barcelona, 08035, Spain

Location

Hospital General Univ. Gregorio Maranon

Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas

Madrid, 28041, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Nefrologia

Valencia, 46017, Spain

Location

Antrim Hospital; Renal Dept

Antrim, 2RL, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

Bristol, BS10 5NB, United Kingdom

Location

Western Infirmary; Division of Cardiovascular and Medical Sciences

Glasgow, G11 6NT, United Kingdom

Location

Royal Liverpool Uni Hospital; Renal Dept

Liverpool, L7 8XP, United Kingdom

Location

Royal London Hospital; Renal Unit

London, E1 1BB, United Kingdom

Location

Manchester Royal Infirmary; Renal Transplant Unit

Manchester, M13 9WL, United Kingdom

Location

Freeman Hospital; Nephrology

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham City Hospital; Transplant Unit

Nottingham, NG5 1PB, United Kingdom

Location

Churchill Hospital; Oxford Transplant Center Renal Transplant Unit

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39807668 DERIVED

• 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.

  PMID: 38700045 DERIVED

• 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.

  PMID: 20353469 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 22, 2006
• Study Start: March 31, 2006
• Primary Completion: August 31, 2008
• Study Completion: August 31, 2009
• Last Updated: March 29, 2018
• Results First Posted: July 5, 2010

Record last verified: 2018-02

Locations

NZ (1); DE (7); BE (3); US (23); AU (3); IT (4); FR (9); RO (2); BR (5); CA (4); ES (6); GB (10); PL (3)