Clinical trial NCT01376804: A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Official title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation, Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 57
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator
timeFrame: 52 weeks
measure: Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator
timeFrame: 52 weeks
measure: Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
timeFrame: 52 weeks
measure: Number of Participants With Biopsy Proven Rejection
timeFrame: 52 Weeks
measure: Number of Participants With Graft Loss
timeFrame: 52 Weeks
measure: Number of Participants With Death
timeFrame: 52 Weeks
measure: Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Pediatric Nephrology
state: Florida
city: Los angeles
country: United States
facility: UCLA Center For Health Sciences; Division of Pediatric Nephrology
state: Louisiana
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Salt Lake City
country: United States
facility: Uni of Utah Health Science Center; Pediatric Nephrology
state: Utah
city: Westmead
country: Australia
facility: Children'S Hospital At Westmead; Department of Nephrology
state: New South Wales
city: South Brisbane, Herston
country: Australia
facility: Mater Childrens Hospital
state: Queensland
city: Parkville
country: Australia
facility: Royal Children'S Hospital; Department of Nephrology
state: Victoria
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP
state: SP
city: Nantes
country: France
facility: CHU de Nantes - Service de pédiatrie
city: Paris
country: France
facility: Hôpital Robert Debré; Nephrologie pediatrique
city: Paris
country: France
facility: Hop Necker Enfants Malades;Nephrologie Pediatrique
city: Hamburg
country: Germany
facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg
city: Hannover
country: Germany
facility: KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover
city: Heidelberg
country: Germany
facility: Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
city: Köln
country: Germany
facility: Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Cuernavaca
country: Mexico
facility: Instituto Mexicano de Transplantes
city: Mexico
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz: Nefrologia Pediatrica
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
city: Göteborg
country: Sweden
facility: Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital For Children
city: Glasgow
country: United Kingdom
facility: Royal Hospital For Sick Children; Dept. of Child Health
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: