Skip to main content
OpenTrials
Completed

NCT Number: NCT07497776

Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome

To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of kidney diseases and Urology

Dhaka, Dhaka Division, 1207, Bangladesh

About this study

Abstract Background: Dyslipidemia is a common complication in children with steroid-sensitive nephrotic syndrome (SSNS), which often persists during remission. It increases the risk of early atherosclerosis, cardiovascular disease, and progressive kidney damage. Lifestyle and dietary measures are often insufficient, and evidence on the use of statins such as atorvastatin in this population remains fairly unexplored.

Objective: To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome.

Methods: This quasi-experimental study was conducted at the department of Pediatric Nephrology & Nephrology department, National Institute of Kidney Diseases & Urology, Dhaka. A total of 100 children aged between 8-18 years with SSNS having dyslipidemia in two consecutive measurements, 1 month apart while in remission and who were free of infection were enrolled in the study. Participants were quasi-randomized into two groups: group A (dietary advice only n=50) (control group) and group B (dietary advice plus atorvastatin, n=50) (intervention group). Lipid profiles (total cholesterol, Triglyceride, Low density Lipoprotein and High Density Lipoprotein) were measured at baseline, 1, 3 and 6 months. During study in total 9 patients were lost to follow up and 2 patients were withdrawn from study. Outcome variable was percentage of patients achieving target levels of lipid profile within 3 months and 6 months in both groups. Safety was also assessed by monitoring of adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 8-18 years with known cases of steroid sensitive nephrotic syndrome
  • LDL ≥ 130 mg/dl in two consecutive serum fasting lipid profile, at least 4 weeks apart
  • while on remission
  • free of acute infection.

Exclusion criteria

  • Children with previously diagnosed hyperlipidemia other than Nephrotic Syndrome.
  • Children with steroid resistant nephrotic syndrome
  • Children already on lipid lowering drugs
  • Secondary nephrotic syndrome.
  • Those parents/patients who refused to participate.
  • Secondary nephrotic syndrome (SLE, amyloidosis etc.) 5. Nephrotic syndrome (initial episode). 6. Children taking Anti TB drug or anticonvulsant drugs. 7. Children having any active liver disease.

Treatment and study plan

atorvastatin

Drug

Atorvastatin 10 mg nightly dose

Other names: Atova/Lipitor

Primary outcomes

  1. percentage of patients achieving target levels of lipid profile

    Time frame: 6 months

    percentage of patients achieving target levels of lipid profile within 3 months and 6 months in both groups

Sponsors and collaborators

Lead sponsor

National Institute of Kidney Disease and Urology (NIKDU)

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.