Lisinopril versus lisinopril and losartan for mild childhood IgA nephropathy: a randomized controlled trial (JSKDC01 study).

Abstract

BACKGROUND:

Persistent proteinuria seems to be a risk factor for progression of renal disease. Its reduction by angiotensin-converting inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) is renoprotective. Our previous pilot study showed that 2-year lisinopril therapy is effective and safe for children with mild IgA nephropathy. When combined with ACEI and ARB, reported results are of greater decrease in proteinuria than monotherapy in chronic glomerulonephritis, including IgA nephropathy. To date, however, there have been no randomized controlled trials in children.

METHODS:

This is an open-label, multicenter, prospective, and randomized phase II controlled trial of 63 children with biopsy-proven proteinuric mild IgA nephropathy. We compared efficacy and safety between patients undergoing lisinopril monotherapy and patients undergoing combination therapy of lisinopril and losartan to determine better treatment for childhood proteinuric mild IgA nephropathy.

RESULTS:

There was no difference in proteinuria disappearance rate (primary endpoint) between the two groups (cumulative disappearance rate of proteinuria at 24 months: 89.3% vs 89% [combination vs monotherapy]). Moreover, there were no significant differences in side effects between the two groups.

CONCLUSIONS:

We propose lisinopril monotherapy as treatment for childhood proteinuric mild IgA nephropathy as there are no advantages of combination therapy.

CLINICAL TRIAL REGISTRATION:

Clinical trial registry, UMIN ID C000000006, https://www.umin.ac.jp .

• Authors: Yuko Shima, Koichi Nakanishi, Mayumi Sako, Mari Saito-Oba, Yuko Hamasaki, Hiroshi Hataya, Masataka Honda, Koichi Kamei, Kenji Ishikura, Shuichi Ito, Hiroshi Kaito, Ryojiro Tanaka, Kandai Nozu, Hidefumi Nakamura, Yasuo Ohashi, Kazumoto Iijima, Norishige Yoshikawa, Japanese Study Group of Kidney Disease in Children (JSKDC)
• Journal: Pediatric nephrology (Berlin, Germany) (Pediatr Nephrol) Vol. 34 Issue 5 Pg. 837-846 (05 2019) ISSN: 1432-198X [Electronic] Germany
• PMID: 30284023 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Lisinopril
• Losartan

Topics

• Adolescent
• Child
• Child, Preschool
• Drug Therapy, Combination (adverse effects, methods)
• Female
• Glomerulonephritis, IGA (complications, diagnosis, drug therapy, pathology)
• Humans
• Kidney Glomerulus (pathology)
• Lisinopril (administration & dosage, adverse effects)
• Losartan (administration & dosage, adverse effects)
• Male
• Prospective Studies
• Proteinuria (diagnosis, drug therapy, etiology, urine)
• Severity of Illness Index
• Treatment Outcome