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Trial record 14 of 101 for:    Valcyte

A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00090766
Recruitment Status : Completed
First Posted : September 6, 2004
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cytomegalovirus Infections
Intervention Drug: valganciclovir [Valcyte]
Enrollment 63
Recruitment Details A total of 63 participants were enrolled in this study conducted from 28 May 2004 to 13 May 2005. The study was conducted at 18 centers in 7 countries.
Pre-assignment Details Participants were screened within 48 hours prior to transplant surgery (Day 1) and received valganciclovir from Day 1.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]). Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS). Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Period Title: Overall Study
Started 17 21 25
Completed 14 19 22
Not Completed 3 2 3
Reason Not Completed
Nephrectomy Planned             0             0             1
Death             1             0             0
Admin             0             2             0
Lost to Follow-up             2             0             2
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years Total
Hide Arm/Group Description Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS). Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS). Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS). Total of all reporting groups
Overall Number of Baseline Participants 17 21 25 63
Hide Baseline Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 21 participants 25 participants 63 participants
0.6  (0.86) 6.9  (3.15) 14.2  (1.54) 8.1  (5.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 21 participants 25 participants 63 participants
Female
9
  52.9%
7
  33.3%
13
  52.0%
29
  46.0%
Male
8
  47.1%
14
  66.7%
12
  48.0%
34
  54.0%
1.Primary Outcome
Title Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
Hide Description Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Time Frame Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population comprised of all participants from studies WP16296, WP16303 and WV16726 who had completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 20 25
Mean (Standard Deviation)
Unit of Measure: mcg*hr/mL
In kidney recipients, n=2, 12, 19 65.2  (16.6) 55  (11.9) 50  (11.6)
In liver recipients, n=9, 6, 2 69.4  (35.4) 58.4  (6.18) 35.6  (2.76)
In heart recipients, n=6, 2, 4 56.3  (23.2) 60  (19.3) 61.2  (26)
2.Primary Outcome
Title Number of Participants With Adverse Events Leading to Dose Interruption or Modification
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose (in mg) was calculated using the algorithm (7 * body surface area * creatinine clearance).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
4 2 3
3.Primary Outcome
Title Number of Participants With Opportunistic Infections
Hide Description Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
Oral Candidiasis 2 0 0
Candidiasis 1 0 0
Herpes Simplex 0 1 0
Cytomegalovirus Antigen Positive 1 0 0
Cytomegalovirus Test Positive 1 0 0
4.Primary Outcome
Title Number of Participants With Any Adverse Events and Any Serious Adverse Events
Hide Description An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
Any AE 17 18 24
Any SAE 13 11 11
5.Primary Outcome
Title Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
Hide Description An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
1 2 0
6.Primary Outcome
Title Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
Hide Description The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Overall Study
Hide Arm/Group Description:
All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
Hemoglobin low, n= 63 6
White blood cell count low, n= 59 3
Lymphocytes low, n= 54 3
Neutrophils low, n= 54 7
Potassium low, n=56 4
Potassium high, n=57 4
Alkaline Phosphatase high, n=40 1
Alanine transaminase high, n=48 1
Total Bilirubin high, n=38 1
Sodium low, n=58 2
Sodium high, n=57 0
Calcium low, n=46 1
Phosphate low, n=43 2
Fasting Glucose low, n=39 1
Uric Acid high, n=21 2
7.Primary Outcome
Title Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
Hide Description The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Overall Study
Hide Arm/Group Description:
All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
Hemoglobin low, n= 63 0
White blood cell count low, n= 59 1
Lymphocytes low, n= 54 3
Neutrophils low, n= 54 4
Potassium low, n=56 0
Potassium high, n=57 2
Alkaline Phosphatase high, n=40 0
Alanine transaminase high, n=48 0
Total Bilirubin high, n=38 0
Sodium low, n=58 0
Sodium high, n=57 1
Calcium low, n=46 3
Phosphate low, n=43 0
Fasting Glucose low, n=39 0
Uric Acid high, n=21 2
8.Secondary Outcome
Title Number of Participants With Cytomegalovirus Disease Over Time
Hide Description Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of valganciclovir.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
0 2 2
9.Secondary Outcome
Title Number of Participants With Treatment Failures
Hide Description Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
2 2 0
10.Secondary Outcome
Title Number of Participants Who Experienced Graft Loss
Hide Description Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
Acute Graft Rejection 1 0 0
Chronic Graft Rejection 0 0 0
Recurrence of Underlying Disease 0 0 0
Technical Complications 0 0 1
Primary Graft Non-Function 0 0 0
Other 0 1 0
11.Secondary Outcome
Title Mean Maximum Plasma Concentration of Valganciclovir Over Time
Hide Description Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Time Frame Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 20 25
Mean (Standard Deviation)
Unit of Measure: mcg/mL
In kidney recipients, n=2, 12, 19 10  (0.04) 8.74  (2.49) 7.85  (2.1)
In liver recipients, n=9, 6, 2 11.7  (3.59) 9.35  (2.33) 5.55  (1.34)
In heart recipients, n=6, 2, 4 8.22  (2.44) 12.5  (1.02) 9.5  (3.34)
12.Secondary Outcome
Title Mean Elimination Half-Life of Valganciclovir Over Time
Hide Description The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
Time Frame Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 20 25
Mean (Standard Deviation)
Unit of Measure: hours
In kidney recipients, n=2, 12, 19 3.1  (0.59) 4.47  (1.37) 5.69  (1.06)
In liver recipients, n=9, 6, 2 2.72  (1.32) 3.61  (0.8) 4.5  (0.25)
In heart recipients, n=6, 2, 4 3.6  (1.73) 2.62  (0.65) 5.05  (0.7)
13.Secondary Outcome
Title Number of Participants Who Experienced Episodes of Rejection Over Time
Hide Description Participants with biopsy proven active rejection are reported.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description:
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
Overall Number of Participants Analyzed 17 21 25
Measure Type: Number
Unit of Measure: participants
5 2 2
Time Frame Up to Week 26
Adverse Event Reporting Description Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
 
Arm/Group Title Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Hide Arm/Group Description Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS). Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS). Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
All-Cause Mortality
Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/17 (76.47%)   11/21 (52.38%)   11/25 (44.00%) 
Blood and lymphatic system disorders       
Anaemia  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Neutropenia  1  0/17 (0.00%)  1/21 (4.76%)  1/25 (4.00%) 
Febrile neutropenia  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Cardiac disorders       
Cardiac failure  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Cardiac tamponade  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders       
Intra−abdominal haemorrhage  1  1/17 (5.88%)  2/21 (9.52%)  0/25 (0.00%) 
Intestinal obstruction  1  0/17 (0.00%)  1/21 (4.76%)  1/25 (4.00%) 
Diarrhoea  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Gastrointestinal haemorrhage  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Gastrointestinal hypomotility  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Gastrooesophageal reflux disease  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Intestinal perforation  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Vomiting  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
General disorders       
Pyrexia  1  1/17 (5.88%)  2/21 (9.52%)  1/25 (4.00%) 
Chest pain  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Influenza like illness  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Hepatobiliary disorders       
Hepatic artery thrombosis  1  1/17 (5.88%)  1/21 (4.76%)  0/25 (0.00%) 
Bile duct stenosis  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Cholangitis  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Hepatic artery stenosis  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Hepatic function abnormal  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Portal vein thrombosis  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Immune system disorders       
Transplant rejection  1  1/17 (5.88%)  0/21 (0.00%)  3/25 (12.00%) 
Infections and infestations       
Cytomegalovirus Viraemia  1  0/17 (0.00%)  2/21 (9.52%)  1/25 (4.00%) 
Epstein−barr virus infectionn  1  1/17 (5.88%)  1/21 (4.76%)  0/25 (0.00%) 
Bacterial sepsis  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Biliary tract infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Ear infection  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Gastroenteritis  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Gastrointestinal infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Liver abscess  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Nasopharyngitis  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Pharyngitis  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Pyelonephritis  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Sepsis  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Upper respiratory tract infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Urinary tract infection  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Viral infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications       
Subdural haematoma  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Investigations       
Cytomegalovirus test positive  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Transaminases increased  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Blood creatinine increased  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Cytomegalovirus antigen positive  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Hepatic enzyme increased  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Metabolism and nutrition disorders       
Metabolic disorder  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Plasmablastic lymphoma  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Nervous system disorders       
Cerebral infarction  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Leukoencephalopathy  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Ureteric obstruction  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Hypoxia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Stridor  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Surgical and medical procedures       
Gastrostomy tube insertion  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Vascular disorders       
Haematoma  1  0/17 (0.00%)  1/21 (4.76%)  0/25 (0.00%) 
Lymphocele  1  0/17 (0.00%)  0/21 (0.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valganciclovir Age Group <= 2 Years Valganciclovir Age Group >2 to < 12 Years Valganciclovir Age Group >= 12 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/17 (100.00%)   17/21 (80.95%)   21/25 (84.00%) 
Blood and lymphatic system disorders       
Anaemia  1  9/17 (52.94%)  4/21 (19.05%)  0/25 (0.00%) 
Neutropenia  1  4/17 (23.53%)  1/21 (4.76%)  1/25 (4.00%) 
Leukocytosis  1  3/17 (17.65%)  1/21 (4.76%)  0/25 (0.00%) 
Leukopenia  1  0/17 (0.00%)  0/21 (0.00%)  2/25 (8.00%) 
Thrombocythaemia  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Thrombocytopenia  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Lymphopenia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Cardiac disorders       
Pericardial Effusion  1  0/17 (0.00%)  1/21 (4.76%)  2/25 (8.00%) 
Bradycardia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Cardiac Disorder  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Left Ventricular Failure  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Sinus Bradycardia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  7/17 (41.18%)  8/21 (38.10%)  6/25 (24.00%) 
Vomiting  1  2/17 (11.76%)  7/21 (33.33%)  7/25 (28.00%) 
Nausea  1  0/17 (0.00%)  2/21 (9.52%)  6/25 (24.00%) 
Constipation  1  0/17 (0.00%)  5/21 (23.81%)  2/25 (8.00%) 
Abdominal pain  1  1/17 (5.88%)  3/21 (14.29%)  1/25 (4.00%) 
Abdominal Distention  1  0/17 (0.00%)  2/21 (9.52%)  1/25 (4.00%) 
Ascites  1  3/17 (17.65%)  0/21 (0.00%)  0/25 (0.00%) 
Gastrointestinal Haemorrhage  1  1/17 (5.88%)  2/21 (9.52%)  0/25 (0.00%) 
Teething  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
General disorders       
Pyrexia  1  5/17 (29.41%)  8/21 (38.10%)  4/25 (16.00%) 
Oedema Peripheral  1  0/17 (0.00%)  0/21 (0.00%)  5/25 (20.00%) 
Irritability  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Catheter Site Discharge  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Catheter Site Inflammation  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Hepatobiliary disorders       
Biliary Tract Disorder  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Hepatic Function Abnormal  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Immune system disorders       
Liver Transplant Rejection  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Transplant Rejection  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Milk Allergy  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Infections and infestations       
Upper Respiratory Tract  1  4/17 (23.53%)  5/21 (23.81%)  7/25 (28.00%) 
Nasopharyngitis  1  1/17 (5.88%)  1/21 (4.76%)  3/25 (12.00%) 
Urinary Tract Infection  1  0/17 (0.00%)  1/21 (4.76%)  4/25 (16.00%) 
Otitis Media  1  1/17 (5.88%)  0/21 (0.00%)  2/25 (8.00%) 
Cellulitis  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Clostridium Colitis  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Epstein-Barr Virus Infection  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Gastroenteritis  1  0/17 (0.00%)  2/21 (9.52%)  0/25 (0.00%) 
Oral Candidiasis  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Pneumonia  1  0/17 (0.00%)  2/21 (9.52%)  0/25 (0.00%) 
Respiratory Syncytial Virus Infection  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Respiratory Tract Infection  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Sepsis  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Abdominal Infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Candidiasis  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Central Line Infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Para Influenzae Virus Infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Pneumonia Bacterial  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Staphylococcal infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Stenotrophomonas infection  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications       
Incision site infection  1  0/17 (0.00%)  2/21 (9.52%)  4/25 (16.00%) 
Procedural pain  1  0/17 (0.00%)  2/21 (9.52%)  1/25 (4.00%) 
Device Failure  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Graft Ischaemia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Postoperative Thoracic procedure complications  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Investigations       
Epstein-Barr Virus Test positive  1  0/17 (0.00%)  2/21 (9.52%)  0/25 (0.00%) 
Blood Albumin Decreased  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
White Blood Cell Count Increased  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Metabolism and nutrition disorders       
Hypomagnesaemia  1  2/17 (11.76%)  4/21 (19.05%)  0/25 (0.00%) 
Hyperkalaemia  1  3/17 (17.65%)  2/21 (9.52%)  0/25 (0.00%) 
Hyperglycaemia  1  1/17 (5.88%)  2/21 (9.52%)  1/25 (4.00%) 
Metabolic Acidosis  1  4/17 (23.53%)  0/21 (0.00%)  0/25 (0.00%) 
Hypokalaemia  1  2/17 (11.76%)  1/21 (4.76%)  0/25 (0.00%) 
Feeding disorder  1  1/17 (5.88%)  1/21 (4.76%)  0/25 (0.00%) 
Hyperphosphataemia  1  1/17 (5.88%)  1/21 (4.76%)  0/25 (0.00%) 
Hypophosphataemia  1  0/17 (0.00%)  2/21 (9.52%)  0/25 (0.00%) 
Hyperuricaemia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Hypoalbuminaemia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Hypoglycaemia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in Extremity  1  0/17 (0.00%)  1/21 (4.76%)  3/25 (12.00%) 
Back pain  1  0/17 (0.00%)  2/21 (9.52%)  0/25 (0.00%) 
Nervous system disorders       
Headache  1  0/17 (0.00%)  0/21 (0.00%)  4/25 (16.00%) 
Convulsion  1  2/17 (11.76%)  1/21 (4.76%)  0/25 (0.00%) 
Dystonia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Encephalomalacia  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Psychiatric disorders       
Agitation  1  0/17 (0.00%)  0/21 (0.00%)  2/25 (8.00%) 
Anxiety  1  0/17 (0.00%)  0/21 (0.00%)  2/25 (8.00%) 
Insomnia  1  1/17 (5.88%)  1/21 (4.76%)  0/25 (0.00%) 
Renal and urinary disorders       
Haematuria  1  0/17 (0.00%)  4/21 (19.05%)  0/25 (0.00%) 
Dysuria  1  0/17 (0.00%)  0/21 (0.00%)  2/25 (8.00%) 
Acute Prerenal failure  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Renal Failure  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/17 (5.88%)  5/21 (23.81%)  1/25 (4.00%) 
Pharyngolaryngeal pain  1  0/17 (0.00%)  1/21 (4.76%)  3/25 (12.00%) 
Pleural Effusion  1  1/17 (5.88%)  2/21 (9.52%)  1/25 (4.00%) 
Rhinorrhoea  1  0/17 (0.00%)  0/21 (0.00%)  4/25 (16.00%) 
Bronchospasm  1  3/17 (17.65%)  0/21 (0.00%)  0/25 (0.00%) 
Atelectasis  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Nasal Congestion  1  0/17 (0.00%)  0/21 (0.00%)  2/25 (8.00%) 
Wheezing  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Pneumothorax  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Stridor  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  1/17 (5.88%)  4/21 (19.05%)  1/25 (4.00%) 
Rash  1  1/17 (5.88%)  2/21 (9.52%)  2/25 (8.00%) 
Acne  1  0/17 (0.00%)  1/21 (4.76%)  3/25 (12.00%) 
Dermatitis  1  1/17 (5.88%)  0/21 (0.00%)  1/25 (4.00%) 
Dermatitis Diaper  1  2/17 (11.76%)  0/21 (0.00%)  0/25 (0.00%) 
Hirsutism  1  0/17 (0.00%)  2/21 (9.52%)  0/25 (0.00%) 
Pruritus Generalised  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Urticaria  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Vascular disorders       
Hypertension  1  4/17 (23.53%)  6/21 (28.57%)  8/25 (32.00%) 
Haematoma  1  1/17 (5.88%)  0/21 (0.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00090766     History of Changes
Other Study ID Numbers: WV16726
First Submitted: September 3, 2004
First Posted: September 6, 2004
Results First Submitted: June 24, 2016
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016