A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

Hoffmann-La Roche57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Kidney Transplantation, Cytomegalovirus Infections

Interventions

valganciclovir [Valcyte]DRUG

Oral, daily for up to 200 days.

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs

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.

Time frame: 52 weeks

Secondary Outcomes

Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator

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.

Time frame: 52 weeks

Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator

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.

Time frame: 52 weeks

Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 15 more locations