A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Completed · Phase 4
Conditions studied: Kidney Transplantation, Cytomegalovirus Infections
In brief
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
Key facts
- Study ID
- NCT01376804
- Run by
- Hoffmann-La Roche
- People needed
- 57
- Starts
- 2011-07-31
- Expected to finish
- 2013-05-31
- Last updated by the study team
- 2017-07-11
Who can join
Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children, 4 months to 16 years of age
- 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
You may not qualify if…
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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