Comparison the effect deferasirox swallow form (Jadenu®) with deferasirox granule (Exjade®) in reduce of serum ferritin in patients with major and intermedia beta thalassemia
Comparison of the effect of swallowing defrazirox (Jadenu®) with granular form (Exjade®) in reducing serum ferritin levels in patients and its effect on Cr and BUN in patients with beta thalassemia major and intermedia
Design
The present study is a randomized controlled clinical trial with a parallel group without blinding in which patients will be randomly divided into two equal groups (n = 33). One group will be given Exjade and the other group will be given Jadenu. .
Settings and conduct
The present study is a randomized controlled clinical trial in which patients will be randomly divided into two equal groups (33 people).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 2 years
Patients diagnosed with thalassemia major and intermedia
Having conscious satisfaction
Serum ferritin above 1000 μg / mL
Exclusion criteria:
Existence of contraindications to the studied drugs (Exjade®) and( Jadenu®)
Patients with GFR ˂40 mL / min / 1.73 m2;
Patients with stunted growth
Patients at high risk for myelodysplasia syndrome (MDS)
Advanced cancer
Platelets below 50 x 109 / L
Patients with knowledge of sensitivity to drugs of the defrazirox group
Patients with liver failure
Patients with gastrointestinal bleeding
Patients with renal insufficiency
Simultaneous use of other iron chelators
Intervention groups
One group receives Exjade intervention and one group receives Jadenu intervention.
Main outcome variables
Serum ferritin level-Serum creatinine level-Blood urea nitrogen level-Presence of gastrointestinal side effects-Satisfaction rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210831052350N1
Registration date:2021-11-20, 1400/08/29
Registration timing:registered_while_recruiting
Last update:2021-11-20, 1400/08/29
Update count:0
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
Fatemeh Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 5382
Email address
fateme_zarei1995@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-15, 1400/08/24
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect deferasirox swallow form (Jadenu®) with deferasirox granule (Exjade®) in reduce of serum ferritin in patients with major and intermedia beta thalassemia
Public title
The effect of Jadenu with Exjade in reducing serum ferritin levels in patients with beta thalassemia major and intermedia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 2 years
Patients diagnosed with thalassemia major and intermedia
Having conscious satisfaction
Serum ferritin above 1000 μg / mL
Exclusion criteria:
Existence of contraindications to the studied drugs (Exjade®) and (Jadenu®)
Patients with GFR ˂40 mL / min / 1.73 m2
Patients with stunted growth
Patients at high risk for myelodysplasia syndrome (MDS)
Advanced cancer
Platelets below 50 x 109 / L
Patients with knowledge of sensitivity to drugs of the defrazirox group
Patients with liver failure
Patients with gastrointestinal bleeding
Patients with renal insufficiency
Simultaneous use of other iron chelators
Age
From 2 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
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 Arak University of Medical Sciences
Street address
No. 6, satarkhan,shahid shiroodi st
City
Arak
Province
Markazi
Postal code
3819765456
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.ARAKMU.REC.1399.251
Health conditions studied
1
Description of health condition studied
major thalasemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
2
Description of health condition studied
intermedia thalasemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
serum ferritin
Timepoint
Sampling every two months
Method of measurement
The patient's serum is separated by centrifuge and given to an auto-analyzer
2
Description
Serum creatinine
Timepoint
Sampling every two months
Method of measurement
The patient's serum is separated by centrifuge and given to an auto-analyzer
3
Description
serum BUN
Timepoint
Sampling every two months
Method of measurement
The patient's serum is separated by centrifuge and given to an auto-analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that receives Jadenu. Jadenu is part of the drug class deferasirox . 33 people are being treated with Deferasirox (Jadenu®) for 6 months. This drug will be given as a swallowable tablet at a dose of 20 mg / kg per day (once a day, daily for 6 months, by Novartis Pharma AG, Basel, Switzerland) to patients in this group. we start the treatment with the dose of 20 mg / kg and increase the dose to 40 mg / kg if needed.
Category
Treatment - Drugs
2
Description
Control group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Vahid Falahati
Street address
Shahid Shirodi Blvd,Rahahan st
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3133 5705
Email
fateme_zarei1995@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Almasi
Street address
No. 2,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3133 5506
Email
modavem@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Vahid Falahati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology
Street address
No. 6,Satarkhan,Shahidshiroodi st
City
Arak
Province
Markazi
Postal code
3819765456
Phone
+98 86 7723 2853
Email
fateme_zarei1995@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Falahati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology
Street address
No. 6,Satarkhan,Shahidshiroodi st
City
Arak
Province
Markazi
Postal code
3819765456
Phone
+98 86 3277 3582
Email
fateme_zarei1995@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Falahati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology
Street address
No. 6,Satarkhan,Shahidshiroodi st
City
Arak
Province
Markazi
Postal code
3819765456
Phone
+98 86 3277 3582
Email
fateme_zarei1995@yahoo.com
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
Due to the privacy of the information, patient information is kept confidential by the project manager.