Clinical trial of comparision of 3and 6 months prophylaxis with valganciclovir for prevention of cytomegalovirus(CMV) disease in children with renal transplantation
This study is a clinical trial for comparison the effect of 3 and 6 months prophylaxis with valganciclovir drug for prevention of cytomegalovirus (CMV) infection in children with renal transplantation. This study is single blind, and the sample population consists of 86 children that have renal transplantation and also receive organs from people who are positive of CMV infection. Thus children that receive organs from negative donors are excluded. The use of Thymoglobuline drug is a important exclusion criteria in this study. We use simple random method in Rasool-Akram and Ali-Asghar hospitals for sampling. By random method, we give the half of the children valganciclovir drug for 3 months and the another half of the children for 6 months by 10-15 mg/kg daily. After that, we follow these children for a year after transplantation(9 months after 3 months prophylaxis and 6 months after 6 months prophylaxis), and do monthly experiments in both groups to compare the incident rate of CMV infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021321062N1
Registration date:2015-05-12, 1394/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-12, 1394/02/22
Registrant information
Name
Niloofar Khosravi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4429 7768
Email address
hoseini.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Expected recruitment start date
2015-03-06, 1393/12/15
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparision of 3and 6 months prophylaxis with valganciclovir for prevention of cytomegalovirus(CMV) disease in children with renal transplantation
Public title
The effect of duration of treatment with valganciclovir in children with renal transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The children who receive organs from people who are CMV positive; The children are 1-14 years-old
Exclusion criteria: The use of Thymoglobuline drug; The children who are effected severely by side effects of valganciclovir drug; for example: severe leukopenia or anemia
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran university of medical sciences
Street address
Iran University of Medical Sciences, between Hemmat highway and Sheykh Fazlolah highway
City
Tehran
Postal code
Approval date
2015-02-15, 1393/11/26
Ethics committee reference number
93-03-30-25001-109010
Health conditions studied
1
Description of health condition studied
renal failure
ICD-10 code
N17
ICD-10 code description
Acute renal failure
2
Description of health condition studied
CMV infection
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
CMV infection
Timepoint
before intervention, 15 days after intervention, every month until 1 year after intervention
Method of measurement
Laboratory methods of Qualitit PCR and PP65
Secondary outcomes
1
Description
side effects of valganciclovir drug like: Anemia and Allergic hypersensitivity
Timepoint
every month after intervention until 1 year
Method of measurement
clinical presentation
Intervention groups
1
Description
control group: treatment with Valganciclovir, 10-15 mg per kg for everyone, daily, for 3 months
Category
Treatment - Drugs
2
Description
intervention group: treatment with valganciclovir, 10-15 mg per kg for everyone, daily, for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Asghar Children Hospital
Full name of responsible person
Dr Rozita Hoseini
Street address
Ali-Asghar Children Hospital, Shahid Vahid Dastgerdi street, Modarres highway
City
Tehran
2
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Dr Nahid Rahim-Zadeh
Street address
Rasool Akram Hospital, Niyayesh street, Sattar-Khan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mehrdad Eftekhar
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ali-Asghar Hospital
Full name of responsible person
Niloofar Khosravi
Position
Medical student
Other areas of specialty/work
Street address
Ali-Asghar Hospital, Vahid Dastgerdi street, Modarres highway
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
Email
niloofarkhosravi@rocketmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ali-Asghar Hospital
Full name of responsible person
Dr Rozita Hoseini
Position
Professor
Other areas of specialty/work
Street address
Vahid Dastgerdi street, Modarres highway,
City
Tehran
Postal code
Phone
+98 21 2222 2041
Fax
Email
rozitahoseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Niloofar Khosravi
Position
Medical student
Other areas of specialty/work
Street address
Number 2, South Khosro street, Sattar-Khan street
City
Tehran
Postal code
Phone
+98 21 4429 7768
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)