Determination and comparison of mean kidney markers in β-thalassemic patients receiving deferasirox or deferoxamine and healthy control group
Design
non-randomized open-label controlled Clinical trial with parallel groups
Settings and conduct
The present study is conducted on children and adolescents over the age of 4 in three groups, Beta-thalassemia patients undergoing therapy for deferasirox, treated with deferoxamine, and a healthy control group in 17th Shahrivar children Hospital, Rasht
Participants/Inclusion and exclusion criteria
inclusion criteria
beta thalassemia major patients receiving deferasirox for more than a year
beta thalassemia major patients receiving deferoxamine for more than a year
healthy control group
exclusion criteria
previous diagnosis of congenital diseases
previous diagnosis of renal functions diseases
acute sign and symptoms of acute kidney disease
Intervention groups
Deferasirox treatment
Deferoxamine treatment
Main outcome variables
kidney function markers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090111001545N4
Registration date:2018-05-05, 1397/02/15
Registration timing:retrospective
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Hamidreza Badeli
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 9523
Email address
badeli@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-02-20, 1396/12/01
Trial completion date
empty
Scientific title
Evaluating the effect of oral iron chelators on markers of renal function in beta-thalassemia major
Public title
Evaluating the effect of oral iron chelators on markers of renal function in beta-thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
beta thalassemia major patients receiving deferasirox for more than a year
beta thalassemia major patients receiving deferoxamine for more than a year
healthy control group
Exclusion criteria:
previous diagnosis of congenital diseases
previous diagnosis of renal functions diseases
acute sign and symptoms of acute kidney disease
Age
From 4 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of guilan University of Medical Sciences
Street address
Siadati
City
Rasht
Province
Guilan
Postal code
4144444444
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
IR.GUMS.REC.1394.349
Health conditions studied
1
Description of health condition studied
Thalassaemia Major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
renal function markers
Timepoint
after on year treatment
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment with defrasirox
Category
Treatment - Drugs
2
Description
Intervention group: treatment with defroxamine
Category
Treatment - Drugs
3
Description
Control group: healthy individuals
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Hamidreza Badeli
Street address
Siadati
City
Rasht
Province
Guilan
Postal code
4144464444
Phone
+98 13 3336 9002
Email
badeli@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Shahid Siadati Street
City
Rasht
Province
Guilan
Postal code
4144444444
Phone
+98 13 3336 9031
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Siadati
City
Rasht
Province
Guilan
Postal code
4144444445
Phone
+98 13 3336 9002
Fax
+98 13 1322 6101
Email
badeli@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Soheil Medical Building, Golsar Cross
City
Rasht
Province
Guilan
Postal code
4144444445
Phone
+98 13 3336 9002
Fax
+98 13 3336 9061
Email
badeli@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Nephrologist and Associate Professor of Guilan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Siadati Street
City
Rasht
Province
Guilan
Postal code
4144444444
Phone
+98 13 3336 9002
Fax
Email
badeli@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD