A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
- Conditions
- Kidney Transplantation, Cytomegalovirus Infections
- Interventions
- Registration Number
- NCT01376804
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Valganciclovir valganciclovir [Valcyte] 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 \[7 \* Body Surface Area \* Creatinine Clearance\].
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs 52 weeks An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
- Secondary Outcome Measures
Name Time Method Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator 52 weeks A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.
Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator 52 weeks A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.
Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant 52 weeks Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories \< 150 CP/mL and above.
Number of Participants With Biopsy Proven Rejection 52 Weeks Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
Number of Participants With Graft Loss 52 Weeks Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
Number of Participants With Death 52 Weeks Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) 52 Weeks All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Trial Locations
- Locations (25)
Instituto Mexicano de Transplantes
🇲🇽Cuernavaca, Mexico
Royal Children'S Hospital; Department of Nephrology
🇦🇺Parkville, Victoria, Australia
UCLA Center For Health Sciences; Division of Pediatric Nephrology
🇺🇸Los angeles, Louisiana, United States
University of Florida Pediatric Nephrology
🇺🇸Gainesville, Florida, United States
Uni of Utah Health Science Center; Pediatric Nephrology
🇺🇸Salt Lake City, Utah, United States
Hop Necker Enfants Malades;Nephrologie Pediatrique
🇫🇷Paris, France
Hôpital Robert Debré; Nephrologie pediatrique
🇫🇷Paris, France
Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
🇪🇸Sevilla, Spain
Hospital Infantil de Mexico Federico Gomez
🇲🇽Mexico, Mexico
Birmingham Children's Hospital
🇬🇧Birmingham, United Kingdom
Bristol Royal Hospital For Children
🇬🇧Bristol, United Kingdom
Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken
🇸🇪Göteborg, Sweden
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario La Paz: Nefrologia Pediatrica
🇪🇸Madrid, Spain
Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln
🇩🇪Köln, Germany
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Children'S Hospital At Westmead; Department of Nephrology
🇦🇺Westmead, New South Wales, Australia
Mater Childrens Hospital
🇦🇺South Brisbane, Herston, Queensland, Australia
Universidade Federal de Sao Paulo - UNIFESP
🇧🇷Sao Paulo, SP, Brazil
CHU de Nantes - Service de pédiatrie
🇫🇷Nantes, France
Universitätsklinikum für Kinder und Jugendmedizin Hamburg
🇩🇪Hamburg, Germany
Centenario Hospital Miguel Hidalgo
🇲🇽Aguascalientes, Mexico
Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
🇩🇪Heidelberg, Germany
KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover
🇩🇪Hannover, Germany
Royal Hospital For Sick Children; Dept. of Child Health
🇬🇧Glasgow, United Kingdom