NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000006

Registered date:01/08/2005

Lisinopril only and a combination of lisinopril and losartan for IgA nephropathy with focal mesangial proliferation in children: A randomized controlled trial of efficacy and safety

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedIgA nephropathy in children
Date of first enrollment2005/01/01
Target sample size110
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Lisinopril for 2 years Lisinopril+losartan for 2 years

Outcome(s)

Primary OutcomeDisappearance rate of proteinuria
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum2years-old
Age maximum18years-old
GenderMale and Female
Include criteria1.Biopsy diagnoses of IgA nephropathy with focal mesangial proliferation, where a renal biopsy has been performed within 4 months before eligibility. 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.
Exclude criteria1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.Medical history of allergy or hypersensitivity reactions to lisinopuril and losartan. 3.Chronic renal dysfunction. 4.Active infectious disease. 5.Severe liver disfunction. 6.History of steroid, immunosupression, ACEI and ARB administration. 7.History of Saireito or dipilidamol administration. 8.Pregnancy. 9.Judged inappropriate for this study by the physicians.

Related Information

Contact

public contact
Name Nakanishi
Address 811-1 KImiidera Wakayama City Japan
Telephone 073-441-0633
E-mail jskdc@wakayama-med.ac.jp
Affiliation Japanese Study Group of Kidney Disease in Children Department of Pediatrics, Wakayama Medical University
scientific contact
Name Norishige Yoshikawa
Address 811-1 Kimiidera Wakayama City Wakayama Japan
Telephone 073-441-0633
E-mail nori@wakayama-med.ac.jp
Affiliation Wakayama Medical University Department of Pediatrics