A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
NCT ID: NCT01376804
Last Updated: 2017-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
57 participants
INTERVENTIONAL
2011-07-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Valganciclovir
Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm \[7 \* Body Surface Area \* Creatinine Clearance\].
valganciclovir [Valcyte]
Oral, daily for up to 200 days.
Interventions
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valganciclovir [Valcyte]
Oral, daily for up to 200 days.
Eligibility Criteria
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Inclusion Criteria
* Patient has received a kidney transplant
* At risk of developing cytomegalovirus disease
* Adequate hematological and renal function
* Able to tolerate oral medication
* Negative pregnancy test for females of childbearing potential
Exclusion Criteria
* Severe uncontrolled diarrhea (more than 5 watery stools per day)
* Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase \[AST (SGOT)\] or alanine aminotransferase \[ALT (SGPT)\]
* Patient requires use of any protocol prohibited concomitant medication
* Previous participation in this clinical study
4 Months
16 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Florida Pediatric Nephrology
Gainesville, Florida, United States
UCLA Center For Health Sciences; Division of Pediatric Nephrology
Los Angeles, Louisiana, United States
Mount Sinai Medical Center
New York, New York, United States
Uni of Utah Health Science Center; Pediatric Nephrology
Salt Lake City, Utah, United States
Children'S Hospital At Westmead; Department of Nephrology
Westmead, New South Wales, Australia
Mater Childrens Hospital
South Brisbane, Herston, Queensland, Australia
Royal Children'S Hospital; Department of Nephrology
Parkville, Victoria, Australia
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, São Paulo, Brazil
CHU de Nantes - Service de pédiatrie
Nantes, , France
Hôpital Robert Debré; Nephrologie pediatrique
Paris, , France
Hop Necker Enfants Malades;Nephrologie Pediatrique
Paris, , France
Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln
Cologne, , Germany
Universitätsklinikum für Kinder und Jugendmedizin Hamburg
Hamburg, , Germany
KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover
Hanover, , Germany
Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
Heidelberg, , Germany
Centenario Hospital Miguel Hidalgo
Aguascalientes, , Mexico
Instituto Mexicano de Transplantes
Cuernavaca, , Mexico
Hospital Infantil de Mexico Federico Gomez
México, , Mexico
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz: Nefrologia Pediatrica
Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
Seville, , Spain
Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken
Gothenburg, , Sweden
Birmingham Children's Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital For Children
Bristol, , United Kingdom
Royal Hospital For Sick Children; Dept. of Child Health
Glasgow, , United Kingdom
Countries
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Other Identifiers
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2010-022514-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV25409
Identifier Type: -
Identifier Source: org_study_id
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