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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01376804

Public ClinicalTrials.gov record NCT01376804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 10:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01376804
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
57 participants

Conditions and interventions

Eligibility (public fields only)

Age range
4 Months to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2011 (Actual)
Primary completion
May 31, 2013 (Actual)
Completion
May 31, 2013 (Actual)
Last update posted
Jul 11, 2017

2011 – 2013

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
University of Florida Pediatric Nephrology Gainesville Florida — —
UCLA Center For Health Sciences; Division of Pediatric Nephrology Los Angeles Louisiana 90095-1752 —
Mount Sinai Medical Center New York New York 10029-6574 —
Uni of Utah Health Science Center; Pediatric Nephrology Salt Lake City Utah 84108 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01376804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 11, 2017 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01376804 live on ClinicalTrials.gov.

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