UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035961 |
|---|---|
| Receipt number | R000040958 |
| Scientific Title | Randomized controlled trial on immunomodulatory Effects of Azithromycin in Children with Steroid Dependent Nephrotic Syndrome |
| Date of disclosure of the study information | 2019/02/26 |
| Last modified on | 2019/02/26 18:18:01 |
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Basic information
Public title
Randomized controlled trial on immunomodulatory Effects of Azithromycin in Children with Steroid Dependent Nephrotic Syndrome
Acronym
Immunomodulatory effect of azithromycin on SDNS
Scientific Title
Randomized controlled trial on immunomodulatory Effects of Azithromycin in Children with Steroid Dependent Nephrotic Syndrome
Scientific Title:Acronym
Immunomodulatory effect of azithromycin on SDNS
Region
| Africa |
Condition
Condition
complteted
Classification by specialty
| Nephrology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the immunomodulatory effects of AZM combined with steroid therapy with that of steroid therapy alone in children with SDNS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of TNF in both studied groups at different points throughout the study period.
Key secondary outcomes
- Reported significant persistent adverse effects of AZM
- Poor compliance of the patients
- Occurrence of relapse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Azithromycin 10mg/kg/d for 3 days and the course was repeated over 5 months
+ prednisone 1.5 mg/kg every other day for 1 month then 1 mg/kg every other day for 2 months then 0.5 mg/kg every other day for 2 months
Interventions/Control_2
prednisone 1.5 mg/kg every other day for 1 month then 1 mg/kg every other day for 2 months then 0.5 mg/kg every other day for 2 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients with idiopathic steroid dependent nephrotic syndrome (SDNS) in relapse
Key exclusion criteria
- Patients have received immunosuppressive or cytotoxic drugs other than steroids.
- Patients with impaired liver functions, or with baseline risk of cardiovascular disease (i.e. prolonged QT syndrome, abnormally slow heart rate, congenital or acquired cardiac diseases or low levels of potassium and magnesium)
- Secondary nephrotic syndrome
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Happy Sawires |
Organization
Cairo University
Division name
Pediatric Nephrology
Zip code
Address
5 El-Lithy Street El-Maadi- Cairo - Egypt
TEL
+201005446448
happy7_kd@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Heba Mostafa |
Organization
Beni Suef University
Division name
Pediatric Nephrology
Zip code
Address
Beni Suef
TEL
+201001516641
Homepage URL
heba_most@yahoo.com
Sponsor or person
Institute
Cairo University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040958
