Assessment of the acceptability of up to 200 Days of Valganciclovir Oral Solution or Tablets in children who have received a Kidney Transplant

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022514-47-GB

Enrollment

Registered

2011-05-17

Start date

2011-09-05

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment and prevention of CMV disease in kidney transplant recipients MedDRA version: 16.0 Level: LLT Classification code 10049107 Term: CMV viraemia System Organ Class: 100000004862 MedDRA version: 16.0 Level: LLT Classification code 10009703 Term: CMV infection System Organ Class: 100000004862 MedDRA version: 16.0 Level: LLT Classification code 10009701 Term: CMV System Organ Class: 100000004848 MedDRA version: 16.0 Level: LLT Classification code 10060577 Term: CMV viremia System Organ C

Interventions

Trade Name: VALCYTE 50 mg/ml powder for oral solution Pharmaceutical Form: Powder for oral solution INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE CAS Number: 175865-59-5 Current Sponsor code: RO10

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Parent or guardian of patient willing and able to give written informed consent; the written assent from the child is also required if he/she is old enough to understand the risks and benefits of the study. 2. Patient has received a kidney transplant. 3. Males or females aged between 4 months and = 16 years. 4. Patient at risk of developing CMV disease (including R+ who are at risk of CMV due to other factors determined by the treating physician). 5. Patient has adequate hematological and renal function defined as: • Absolute neutrophil count (ANC) >1300 cells/µL • Platelet count >40,000 cells/µL • Hemoglobin >8.0 g/dL • Estimated Schwartz creatinine clearance (>15 mL/min) to allow for dosing according to algorithm 6. Patient is able to tolerate oral medication (any standard practice tube feeding is acceptable). 7. Negative pregnancy test (blood or urine) for females of child bearing potential before initiation of valganciclovir treatment. 8. Patients of reproductive potential agree to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception). Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir, ganciclovir or valganciclovir (or excipients) in the past. 2. Patient has severe, uncontrolled diarrhea (more than 5 watery stools per day). 3. Patient has liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT). 4. Patient requires use of any protocol prohibited concomitant medications. 5. Patient has previously participated in this clinical study. 6. Patient is a lactating female who will not discontinue nursing prior to study entry. 7. Patient is simultaneously participating in another clinical study except as approved by the Sponsor.

Design outcomes

Primary

Measure	Time frame
Main Objective: • The primary objective of this study is to describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients.;Secondary Objective: • To describe the incidence of CMV infection (viremia) and disease (CMV syndrome or tissue invasive CMV) within the first 52 weeks post transplant. • To describe the incidence and nature of CMV resistance to ganciclovir (mutations in UL97 and/or UL54). ;Primary end point(s): To describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients;Timepoint(s) of evaluation of this end point: Up to 52 weeks post-transplant	—

Measure

Time frame

Main Objective: • The primary objective of this study is to describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients.;Secondary Objective: • To describe the incidence of CMV infection (viremia) and disease (CMV syndrome or tissue invasive CMV) within the first 52 weeks post transplant. • To describe the incidence and nature of CMV resistance to ganciclovir (mutations in UL97 and/or UL54). ;Primary end point(s): To describe the tolerability profile of up to 200 days prophylaxis of valganciclovir oral solution and tablets in pediatric kidney transplant recipients;Timepoint(s) of evaluation of this end point: Up to 52 weeks post-transplant

—

Secondary

Measure	Time frame
Secondary end point(s): To describe the incidence of CMV infection and disease within the first 52 weeks post-transplant To describe the incidence and nature of resistance to ganciclovir;Timepoint(s) of evaluation of this end point: Up to 52 weeks post-transplant	—

Countries

Australia, Brazil, France, Germany, Mexico, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026