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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01376804
First received: June 17, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation, Cytomegalovirus Infections
Drug: valganciclovir [Valcyte]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.

  • Number of Participants With Graft Loss [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.

  • Number of Participants With Death [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.


Enrollment: 57
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valganciclovir
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]
Oral, daily for up to 200 days.

  Eligibility

Ages Eligible for Study:   4 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376804

  Show 25 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01376804     History of Changes
Other Study ID Numbers: NV25409, 2010-022514-47
Study First Received: June 17, 2011
Results First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014