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Trial record 10 of 102 for:    Valcyte

A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney 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: NCT01376804
Recruitment Status : Completed
First Posted : June 20, 2011
Results First Posted : April 28, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Kidney Transplantation, Cytomegalovirus Infections
Intervention Drug: valganciclovir [Valcyte]
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valganciclovir
Hide Arm/Group Description 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 (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Period Title: Treatment Period
Started 57
Received Study Drug 56
Completed 49
Not Completed 8
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             6
Patient did not receive study drug             1
Period Title: Follow-up Period
Started 55 [1]
Completed 55
Not Completed 0
[1]
6 of the 7 patients who withdrew from treatment continued to the Follow-up Period.
Arm/Group Title Valganciclovir
Hide Arm/Group Description 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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
Baseline measures were based on the Intent-to-treat population that included all enrolled patients who had taken at least one dose of study drug.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants
≤ 2 Years 6
> 2 to < 12 Years 18
≥ 12 Years 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
25
  44.6%
Male
31
  55.4%
1.Primary Outcome
Title Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs
Hide Description

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.

Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all enrolled patients who received at least one dose of study medication and had at least one post-baseline assessment of safety.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Adverse Events 56
Serious Adverse Events 41
Withdrawals due to AE 6
2.Secondary Outcome
Title Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
3
3.Secondary Outcome
Title Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
CMV Syndrome 1
Tissue Invasive CMV 0
4.Secondary Outcome
Title Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled patients who had taken at least one dose of study medication.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
No CMV DNA Detected 30
< 150 CP/mL 16
150 to 1,000 CP/mL 6
1,001 to 5,000 CP/mL 3
> 5,000 CP/mL 1
5.Secondary Outcome
Title Number of Participants With Biopsy Proven Rejection
Hide Description Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled patients who had taken at least one dose of study medication.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
≤ 2 Years 1
>2 to <12 Years 1
≥ 12 Years 3
6.Secondary Outcome
Title Number of Participants With Graft Loss
Hide Description Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled patients who had taken at least one dose of study medication.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
0
7.Secondary Outcome
Title Number of Participants With Death
Hide Description [Not Specified]
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled patients who had taken at least one dose of study medication.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
0
8.Secondary Outcome
Title Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)
Hide Description All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.
Time Frame 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients meeting the resistance analysis criteria are included into the resistance analysis.
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Participants
UL54 0
UL97 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valganciclovir
Hide Arm/Group Description 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 mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
All-Cause Mortality
Valganciclovir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Valganciclovir
Affected / at Risk (%)
Total   41/56 (73.21%) 
Blood and lymphatic system disorders   
Neutropenia  1  5/56 (8.93%) 
Leukopenia  1  2/56 (3.57%) 
Pancytopenia  1  2/56 (3.57%) 
Anaemia  1  1/56 (1.79%) 
Bicytopenia  1  1/56 (1.79%) 
Eye disorders   
Papilloedema  1  1/56 (1.79%) 
Gastrointestinal disorders   
Abdominal Pain  1  1/56 (1.79%) 
Aphthous Stomatitis  1  1/56 (1.79%) 
Nausea  1  1/56 (1.79%) 
Vomiting  1  1/56 (1.79%) 
General disorders   
Device Leakage  1  1/56 (1.79%) 
Immune system disorders   
Transplant Rejection  1  3/56 (5.36%) 
Kidney Transplant Rejection  1  1/56 (1.79%) 
Infections and infestations   
Urinary Tract Infection  1  7/56 (12.50%) 
Escherichia Urinary Tract Infection  1  5/56 (8.93%) 
Gastroenteritis  1  4/56 (7.14%) 
Viral Upper Respiratory Tract Infection  1  3/56 (5.36%) 
Bacterial Pyelonephritis  1  2/56 (3.57%) 
Peritonitis  1  2/56 (3.57%) 
Pyelonephritis  1  2/56 (3.57%) 
Viral Infection  1  2/56 (3.57%) 
Chronic Sinusitis  1  1/56 (1.79%) 
Diarrhoea Infectious  1  1/56 (1.79%) 
Gastroenteritis Norovirus  1  1/56 (1.79%) 
Gastrointestinal Protozoal Infection  1  1/56 (1.79%) 
Gastrointestinal Viral Infection  1  1/56 (1.79%) 
Infection  1  1/56 (1.79%) 
Pneumonia Mycoplasmal  1  1/56 (1.79%) 
Pneumonia Respiratory Syncytial Viral  1  1/56 (1.79%) 
Pyelonephritis Acute  1  1/56 (1.79%) 
Rotavirus Infection  1  1/56 (1.79%) 
Septic Shock  1  1/56 (1.79%) 
Urinary Tract Infection Bacterial  1  1/56 (1.79%) 
Urosepsis  1  1/56 (1.79%) 
Varicella  1  1/56 (1.79%) 
Injury, poisoning and procedural complications   
Complications Of Transplant Surgery  1  1/56 (1.79%) 
Complications Of Transplanted Kidney  1  1/56 (1.79%) 
Investigations   
Blood Creatinine Increased  1  5/56 (8.93%) 
HLA Marker Study Positive  1  1/56 (1.79%) 
Metabolism and nutrition disorders   
Dehydration  1  2/56 (3.57%) 
Hyponatraemia  1  1/56 (1.79%) 
Type 1 Diabetes Mellitus  1  1/56 (1.79%) 
Nervous system disorders   
Benign Intracranial Hypertension  1  1/56 (1.79%) 
Convulsion  1  1/56 (1.79%) 
Headache  1  1/56 (1.79%) 
Renal and urinary disorders   
Bladder Dysfunction  1  1/56 (1.79%) 
Neurogenic Bladder  1  1/56 (1.79%) 
Proteinuria  1  1/56 (1.79%) 
Ureteric Obstruction  1  1/56 (1.79%) 
Urethral Obstruction  1  1/56 (1.79%) 
Urinary Tract Obstruction  1  1/56 (1.79%) 
Vesicoureteric Reflux  1  1/56 (1.79%) 
Respiratory, thoracic and mediastinal disorders   
Tonsillar Hypertrophy  1  1/56 (1.79%) 
Surgical and medical procedures   
Vesicoureteral Reflux Surgery  1  1/56 (1.79%) 
Vascular disorders   
Hypertension  1  1/56 (1.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valganciclovir
Affected / at Risk (%)
Total   56/56 (100.00%) 
Blood and lymphatic system disorders   
Leukopenia  1  12/56 (21.43%) 
Neutropenia  1  12/56 (21.43%) 
Anaemia  1  10/56 (17.86%) 
Gastrointestinal disorders   
Diarrhoea  1  18/56 (32.14%) 
Abdominal pain  1  9/56 (16.07%) 
Vomiting  1  6/56 (10.71%) 
Abdominal pain upper  1  4/56 (7.14%) 
Nausea  1  4/56 (7.14%) 
Constipation  1  3/56 (5.36%) 
General disorders   
Pyrexia  1  9/56 (16.07%) 
Oedema peripheral  1  3/56 (5.36%) 
Infections and infestations   
Upper respiratory tract infection  1  20/56 (35.71%) 
Urinary tract infection  1  13/56 (23.21%) 
Nasopharyngitis  1  6/56 (10.71%) 
BK virus infection  1  5/56 (8.93%) 
Pharyngitis  1  4/56 (7.14%) 
Escherichia urinary tract infection  1  3/56 (5.36%) 
Gastroenteritis  1  3/56 (5.36%) 
Investigations   
Blood creatinine increased  1  7/56 (12.50%) 
Weight increased  1  4/56 (7.14%) 
Metabolism and nutrition disorders   
Hyperkalaemia  1  4/56 (7.14%) 
Hypomagnesaemia  1  4/56 (7.14%) 
Metabolic acidosis  1  3/56 (5.36%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  4/56 (7.14%) 
Arthralgia  1  3/56 (5.36%) 
Nervous system disorders   
Headache  1  12/56 (21.43%) 
Tremor  1  10/56 (17.86%) 
Dizziness  1  3/56 (5.36%) 
Psychiatric disorders   
Insomnia  1  3/56 (5.36%) 
Renal and urinary disorders   
Dysuria  1  10/56 (17.86%) 
Haematuria  1  6/56 (10.71%) 
Renal tubular acidosis  1  5/56 (8.93%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/56 (10.71%) 
Nasal congestion  1  3/56 (5.36%) 
Oropharyngeal pain  1  3/56 (5.36%) 
Skin and subcutaneous tissue disorders   
Acne  1  3/56 (5.36%) 
Vascular disorders   
Hypertension  1  8/56 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01376804     History of Changes
Other Study ID Numbers: NV25409
2010-022514-47 ( EudraCT Number )
First Submitted: June 17, 2011
First Posted: June 20, 2011
Results First Submitted: March 27, 2014
Results First Posted: April 28, 2014
Last Update Posted: July 11, 2017