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

February 28, 2018 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Valcyte
Drug: Valganciclovir
900 mg orally daily for up to 200 days
Other Names:
  • 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 100 days
Other Names:
  • Valcyte
Drug: Valganciclovir
900 mg orally daily for up to 200 days
Other Names:
  • Valcyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post-transplant
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.
9 months post-transplant
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.
18 months post-transplant
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.
24 months post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2006

Primary Completion (Actual)

August 31, 2008

Study Completion (Actual)

August 31, 2009

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NT18435

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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