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

NCT01376804 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: NV254092010-022514-47
• Study Type: interventional
• Target: 57
• Locations: 9 countries
• Sites: 25

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.

Conditions

Kidney Transplantation, Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (7)

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

  52 weeks

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

  52 weeks

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

  52 weeks

• Number of Participants With Biopsy Proven Rejection

  52 Weeks

• Number of Participants With Graft Loss

  52 Weeks

Study Arms (1)

Valganciclovir

EXPERIMENTAL

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 \[7 \* Body Surface Area \* Creatinine Clearance\].

Drug: valganciclovir [Valcyte]

Interventions

valganciclovir [Valcyte] DRUG

Oral, daily for up to 200 days.

Valganciclovir

Eligibility Criteria

• Age: 4 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (25)

University of Florida Pediatric Nephrology

Gainesville, Florida, United States

Location

UCLA Center For Health Sciences; Division of Pediatric Nephrology

Los Angeles, Louisiana, 90095-1752, United States

Location

Mount Sinai Medical Center

New York, New York, 10029-6574, United States

Location

Uni of Utah Health Science Center; Pediatric Nephrology

Salt Lake City, Utah, 84108, United States

Location

Children'S Hospital At Westmead; Department of Nephrology

Westmead, New South Wales, 2145, Australia

Location

Mater Childrens Hospital

South Brisbane, Herston, Queensland, 4029, Australia

Location

Royal Children'S Hospital; Department of Nephrology

Parkville, Victoria, 3052, Australia

Location

Universidade Federal de Sao Paulo - UNIFESP

São Paulo, São Paulo, 04038-002, Brazil

Location

CHU de Nantes - Service de pédiatrie

Nantes, 44093, France

Location

Hôpital Robert Debré; Nephrologie pediatrique

Paris, 75019, France

Location

Hop Necker Enfants Malades;Nephrologie Pediatrique

Paris, 75743, France

Location

Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln

Cologne, 50937, Germany

Location

Universitätsklinikum für Kinder und Jugendmedizin Hamburg

Hamburg, 20246, Germany

Location

KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover

Hanover, 30625, Germany

Location

Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg

Heidelberg, 69120, Germany

Location

Centenario Hospital Miguel Hidalgo

Aguascalientes, 20230, Mexico

Location

Instituto Mexicano de Transplantes

Cuernavaca, 62428, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

México, 06720, Mexico

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz: Nefrologia Pediatrica

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

Seville, 41013, Spain

Location

Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken

Gothenburg, 41345, Sweden

Location

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

Bristol Royal Hospital For Children

Bristol, BS2 8BJ, United Kingdom

Location

Royal Hospital For Sick Children; Dept. of Child Health

Glasgow, G3 8SJ, United Kingdom

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 20, 2011
• Study Start: July 31, 2011
• Primary Completion: May 31, 2013
• Study Completion: May 31, 2013
• Last Updated: July 11, 2017
• Results First Posted: April 28, 2014

Record last verified: 2017-06

Locations

ES (3); AU (3); BR (1); FR (3); ME (3); GB (3); US (4); DE (4); SE (1)