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

Primary Purpose

Cytomegalovirus Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valganciclovir
Valganciclovir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uni of Alabama At Birmingham
  • National Institute of Transplantation
  • UCLA Medical Center
  • Ucsd Medical Center; Kidney Transplantation
  • California Pacific Medical Center
  • Uni of California San Francisco; Transplant Services
  • Lifelink Healthcare Inst.
  • Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program
  • Indiana Uni Medical Center; Surgery & Microbiology/Immunology
  • New England Medical Center; Division of Transplant Surgery
  • Uni of Michigan Medical Center
  • Uni of Minnesota Medical Center; Dept of Surgery
  • Hackensack University Medical Center
  • St. Barnabas Medical Center
  • Robert Wood Johnson Uni Hospital; Anesthesia
  • Wake Forest Uni School of Medicine; Section on Infectious Diseases
  • Oregon Health Sciences Uni ; Division of Nephrology
  • Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery
  • Uni of Pennslyvania Medical Center
  • Vanderbilt Uni ; Divison of Nephrology
  • Texas Transplant Inst.
  • Uni of Texas Health Science Center At San Antonio; Organ Transplant Program
  • Uni of Washington Medical Center; Division of Allergy & Infectious Diseases
  • Royal Prince Alfred Hospital; Renal Transplant Unit
  • Monash Medical Centre; Renal Transplant Unit
  • Royal Melbourne Hospital; Nephrology
  • Clin Univ de Bxl Hôpital Erasme
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • Santa Casa de Misericordia de Porto Alegre
  • Hospital das Clinicas - UFRGS
  • Hospital das Clinicas - UNICAMP
  • Hospital Israelita Albert Einstein; Intensive Care Unit
  • Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio
  • Uni of Alberta Hospital
  • St. Joseph's Healthcare Hamilton
  • Toronto General Hospital
  • Mcgill University - Royal Victoria Hospital; Oncology
  • Hopital Pellegrin; Departement Nephrologie
  • Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
  • Hopital Lapeyronie; Nephrologie
  • Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
  • Ch Pitie Salpetriere; Urologie
  • Hopital Civil; Clinique Medicale
  • CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation
  • Hopital Bretonneau; Nephrologie Transplantations
  • Hopitaux De Brabois; Nephrologie
  • Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
  • Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin
  • Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
  • Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse
  • Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur
  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I
  • Klinikum der Universitaet Regensburg; Nephrologie
  • POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo
  • ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
  • Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto
  • Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive
  • Auckland City Hospital; Renal Unit, Level 15
  • Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj
  • Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii
  • Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej
  • Institutul de Urologie Si Transplant Renal Fundeni
  • Institutul de Urologie Si Transplant Renal Cluj Napoca
  • Hospital Universitari de Bellvitge; Servicio de Nefrologia
  • Hospital de Cruces; Servicio de Enfermedades Infecciosas
  • Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
  • Hospital General Univ. Gregorio Maranon
  • Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas
  • Hospital Universitario Dr. Peset; Servicio de Nefrologia
  • Antrim Hospital; Renal Dept
  • Queen Elizabeth Hospital
  • SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre
  • Western Infirmary; Division of Cardiovascular and Medical Sciences
  • Royal Liverpool Uni Hospital; Renal Dept
  • Royal London Hospital; Renal Unit
  • Manchester Royal Infirmary; Renal Transplant Unit
  • Freeman Hospital; Nephrology
  • Nottingham City Hospital; Transplant Unit
  • Churchill Hospital; Oxford Transplant Center Renal Transplant Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Valganciclovir up to 100 days

Valganciclovir up to 200 days

Arm Description

Valganciclovir for up to 100 days post kidney transplant

Valganciclovir for up to 200 days post kidney transplant

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 21, 2006
Last Updated
February 28, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00294515
Brief Title
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Acronym
IMPACT
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 31, 2006 (Actual)
Primary Completion Date
August 31, 2008 (Actual)
Study Completion Date
August 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valganciclovir up to 100 days
Arm Type
Experimental
Arm Description
Valganciclovir for up to 100 days post kidney transplant
Arm Title
Valganciclovir up to 200 days
Arm Type
Active Comparator
Arm Description
Valganciclovir for up to 200 days post kidney transplant
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Valcyte
Intervention Description
900 mg orally daily for up to 100 days
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Valcyte
Intervention Description
900 mg orally daily for up to 200 days
Primary Outcome Measure Information:
Title
Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
Description
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.
Time Frame
12 months post-transplant
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
Description
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.
Time Frame
6 months post-transplant
Title
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
Description
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.
Time Frame
9 months post-transplant
Title
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
Description
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.
Time Frame
18 months post-transplant
Title
Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
Description
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.
Time Frame
24 months post-transplant

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
20353469
Citation
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.
Results Reference
derived
Links:
URL
http://www.roche-trials.com/studyResultGet.action?studyResultNumber=NT18435
Description
Clinical Study Report Synopsis

Learn more about this trial

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

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