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

National Institute of Kidney Disease and Urology (NIKDU)

Status and phase: Completed; Phase 4

Conditions: Dyslipidaemia

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07497776

NIKDU-Bangla

Details and patient eligibility

About

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

Full description

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 During study in total 9 patients were lost to follow up and 2 patients were withdrawn from study.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.

Enrollment: 100 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

  4. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control arm/Placebo arm

No Intervention group

Description:

Dietary Advice

Intervention arm/ Atorvastatin

Experimental group

Description:

Dietary advice plus atorvastatin

Treatment:

Drug: Atorvastatin