UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial on immunomodulatory Effects of Azithromycin in Children with Steroid Dependent Nephrotic Syndrome
Title of the study (Brief title)	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	Happy Sawires
Organization	Cairo University
Division name	Pediatric Nephrology
Address	5 El-Lithy Street El-Maadi- Cairo - Egypt
TEL	+201005446448
Email	happy7_kd@yahoo.com

Public contact
Name of contact person	Heba Mostafa
Organization	Beni Suef University
Division name	Pediatric Nephrology
Address	Beni Suef
TEL	+201001516641
Homepage URL
Email	heba_most@yahoo.com

Sponsor
Institute	Cairo University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040958