Back to resultsA Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Primary Purpose
Kidney Transplantation, Cytomegalovirus Infections
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
valganciclovir [Valcyte]
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplantation, Cytomegalovirus Infections
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
Sites / Locations
- University of Florida Pediatric Nephrology
- UCLA Center For Health Sciences; Division of Pediatric Nephrology
- Mount Sinai Medical Center
- Uni of Utah Health Science Center; Pediatric Nephrology
- Children'S Hospital At Westmead; Department of Nephrology
- Mater Childrens Hospital
- Royal Children'S Hospital; Department of Nephrology
- Universidade Federal de Sao Paulo - UNIFESP
- CHU de Nantes - Service de pédiatrie
- Hôpital Robert Debré; Nephrologie pediatrique
- Hop Necker Enfants Malades;Nephrologie Pediatrique
- Universitätsklinikum für Kinder und Jugendmedizin Hamburg
- KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover
- Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
- Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln
- Centenario Hospital Miguel Hidalgo
- Instituto Mexicano de Transplantes
- Hospital Infantil de Mexico Federico Gomez
- Hospital Universitari Vall d'Hebron
- Hospital Universitario La Paz: Nefrologia Pediatrica
- Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
- Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken
- Birmingham Children's Hospital
- Bristol Royal Hospital For Children
- Royal Hospital For Sick Children; Dept. of Child Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valganciclovir
Arm Description
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].
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
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
Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
Number of Participants With Graft Loss
Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
Number of Participants With Death
Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01376804
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 31, 2011 (Actual)
Primary Completion Date
May 31, 2013 (Actual)
Study Completion Date
May 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Cytomegalovirus Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valganciclovir
Arm Type
Experimental
Arm Description
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].
Intervention Type
Drug
Intervention Name(s)
valganciclovir [Valcyte]
Intervention Description
Oral, daily for up to 200 days.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
Description
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 Outcome Measure Information:
Title
Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator
Description
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
Title
Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator
Description
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
Title
Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
Description
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.
Time Frame
52 weeks
Title
Number of Participants With Biopsy Proven Rejection
Description
Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
Time Frame
52 Weeks
Title
Number of Participants With Graft Loss
Description
Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
Time Frame
52 Weeks
Title
Number of Participants With Death
Time Frame
52 Weeks
Title
Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
Description
All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida Pediatric Nephrology
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
UCLA Center For Health Sciences; Division of Pediatric Nephrology
City
Los angeles
State/Province
Louisiana
ZIP/Postal Code
90095-1752
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Uni of Utah Health Science Center; Pediatric Nephrology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Children'S Hospital At Westmead; Department of Nephrology
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Childrens Hospital
City
South Brisbane, Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Children'S Hospital; Department of Nephrology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Universidade Federal de Sao Paulo - UNIFESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-002
Country
Brazil
Facility Name
CHU de Nantes - Service de pédiatrie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Robert Debré; Nephrologie pediatrique
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hop Necker Enfants Malades;Nephrologie Pediatrique
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Universitätsklinikum für Kinder und Jugendmedizin Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Centenario Hospital Miguel Hidalgo
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Instituto Mexicano de Transplantes
City
Cuernavaca
ZIP/Postal Code
62428
Country
Mexico
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz: Nefrologia Pediatrica
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Birmingham Children's Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Bristol Royal Hospital For Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Royal Hospital For Sick Children; Dept. of Child Health
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
We'll reach out to this number within 24 hrs