UMIN-CTR Clinical Trial

Basic information
Public title	Lisinopril for IgA nephropathy with focal mesangial proliferation in children
Acronym	Lisinopril for IgA nephropathy with focal mesangial proliferation in children
Scientific Title	Lisinopril for IgA nephropathy with focal mesangial proliferation in children
Scientific Title:Acronym	Lisinopril for IgA nephropathy with focal mesangial proliferation in children
Region	Japan

Condition
Condition	IgA nephropathy in children
Classification by specialty	Nephrology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate efficacy and safety of lisinopril for IgA nephropathy with focal mesangial proliferation in children.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disappearance rate of proteinuria
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Lisinopril for 2 years
Interventions/Control_2
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	2 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Biopsy diagnoses of IgA nephropathy with focal mesangial proliferation. 2.Proteinuria with a urinary protein-creatinine ratio >0.2. 4.Aged 2 to 18 years. 5.Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria	1.Other renal or systemic forms defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.Medical history of allergy or hypersensitivity reactions to lisinopuril. 3.Chronic renal dysfunction. 4.Active infectious disease. 5.Severe liver disfunction. 6.History of steroid, immunosupression, ACEI, ARB, Saireito and dipilidamol administration. 7.Pregnancy. 8.Judged inappropriate for this study by the physicians.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norishige Yoshikawa
Organization	Wakayama Medical University
Division name	Department of Pediatrics
Zip code
Address	811-1 Kimiidera Wakayama City Wakayama
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The Japanese Pediatric IgA Nephropathy of Treatment Study Group
Division name	Department of Pediatrics, Wakayama Medical University
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	The Japanese Pediatric IgA Nephropathy of Treatment Study Group
Institute
Department

Funding Source
Organization	The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2006 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

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	1998 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date	1998 Year 08 Month 01 Day
Last follow-up date	2005 Year 07 Month 01 Day
Date of closure to data entry	2006 Year 07 Month 01 Day
Date trial data considered complete	2006 Year 07 Month 01 Day
Date analysis concluded	2006 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2006 Year 03 Month 27 Day
Last modified on	2014 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000467

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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