Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome.
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 During study in total 9 patients were lost to follow up and 2 patients were withdrawn from study.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm/Placebo arm | No Intervention | Dietary Advice | |
| Intervention arm/ Atorvastatin | Experimental | Dietary advice plus atorvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin 10 mg nightly dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients achieving target levels of lipid profile | percentage of patients achieving target levels of lipid profile within 3 months and 6 months in both groups | 6 months |
Not provided
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Saieef Zaman, MD | National institute of kidney Disease & Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of kidney diseases and Urology | Dhaka | Dhaka Division | 1207 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Roy, R. et al. (2024). "Clinical Practice Recommendations for Pediatric Nephrotic Syndrome. [online] Available at: https://www.researchgate.net/publication/380032208_Clinical_Practice_Recommenda tions_for_Pediatric_Nephrotic_Syndrome_ [Accessed 15 Sep. 2025]. | ||
| 34556300 | Background | Rovin BH, Adler SG, Barratt J, Bridoux F, Burdge KA, Chan TM, Cook HT, Fervenza FC, Gibson KL, Glassock RJ, Jayne DRW, Jha V, Liew A, Liu ZH, Mejia-Vilet JM, Nester CM, Radhakrishnan J, Rave EM, Reich HN, Ronco P, Sanders JF, Sethi S, Suzuki Y, Tang SCW, Tesar V, Vivarelli M, Wetzels JFM, Lytvyn L, Craig JC, Tunnicliffe DJ, Howell M, Tonelli MA, Cheung M, Earley A, Floege J. Executive summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4):753-779. doi: 10.1016/j.kint.2021.05.015. | |
| 40254391 |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention (2024). Child and Teen BMI Categories. \[online\] BMI. | View source |
Not provided
Data mangement and renrollment analysis and results
27/01/2024 to 31/03/2026
Who : Researchers, What : Results and Data, How : Publication, Correspondent person
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2024 | Mar 23, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2024 | Mar 23, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009401 | Nephrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
This quasi-experimental study
Not provided
Not provided
Not provided
Not provided
| Background |
| Kidney Disease: Improving Global Outcomes (KDIGO) Nephrotic Syndrome In Children Work Group; Floege J, Gibson KL, Vivarelli M, Liew A, Radhakrishnan J, Rovin BH. KDIGO 2025 Clinical Practice Guideline for the Management of Nephrotic Syndrome in Children. Kidney Int. 2025 May;107(5S):S241-S289. doi: 10.1016/j.kint.2024.11.007. No abstract available. |
| 36494853 | Background | Kamel AS, AlGhawass MME, Sayed MA, Roby SA. Evaluation of carotid intima media thickness in children with idiopathic nephrotic syndrome. Ital J Pediatr. 2022 Dec 9;48(1):195. doi: 10.1186/s13052-022-01383-7. |
| 38319465 | Background | Carboni J, Thomas E, Gipson DS, Brady TM, Srivastava T, Selewski DT, Greenbaum LA, Wang CS, Dell KM, Kaskel F, Massengill S, Reidy K, Tran CL, Trachtman H, Lafayette R, Almaani S, Hingorani S, Gbadegesin R, Gibson KL, Sethna CB; Nephrotic Syndrome Study Network (NEPTUNE)*. Longitudinal analysis of blood pressure and lipids in childhood nephrotic syndrome. Pediatr Nephrol. 2024 Jul;39(7):2161-2170. doi: 10.1007/s00467-024-06301-z. Epub 2024 Feb 6. |
| Background | Bagga , A. and Srivastava, R. (2025). Pediatric Nephrology. 7th ed. New Delhi, India: Jaypee Brothers Medical Publishers, pp.266-289. |
| 36269406 | Background | Trautmann A, Boyer O, Hodson E, Bagga A, Gipson DS, Samuel S, Wetzels J, Alhasan K, Banerjee S, Bhimma R, Bonilla-Felix M, Cano F, Christian M, Hahn D, Kang HG, Nakanishi K, Safouh H, Trachtman H, Xu H, Cook W, Vivarelli M, Haffner D; International Pediatric Nephrology Association. IPNA clinical practice recommendations for the diagnosis and management of children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol. 2023 Mar;38(3):877-919. doi: 10.1007/s00467-022-05739-3. Epub 2022 Oct 21. |
| 27165836 | Background | Vaziri ND. Disorders of lipid metabolism in nephrotic syndrome: mechanisms and consequences. Kidney Int. 2016 Jul;90(1):41-52. doi: 10.1016/j.kint.2016.02.026. Epub 2016 Apr 26. |
| Background | Yap, H.-K., Teo, S., Lu, L. and Ng, K.-H. (2024). Pediatric Nephrology On-The-Go. 5th ed. Singapore: World Scientific Publishing Company. |
| Background | Hoque, S.S. et al. (2022) 'Comparison of Lipid Profile in Different Types of Steroid Sensitive Idiopathic Relapsing Nephrotic Syndrome in Children during Active Disease and Remission,' Medicine Today, 34(2), pp. 111-116. https://doi.org/10.3329/medtoday.v34i2.61424. |
| 31302760 | Background | Hari P, Khandelwal P, Smoyer WE. Dyslipidemia and cardiovascular health in childhood nephrotic syndrome. Pediatr Nephrol. 2020 Sep;35(9):1601-1619. doi: 10.1007/s00467-019-04301-y. Epub 2019 Jul 13. |
| 30091061 | Background | Hari P, Khandelwal P, Satpathy A, Hari S, Thergaonkar R, Lakshmy R, Sinha A, Bagga A. Effect of atorvastatin on dyslipidemia and carotid intima-media thickness in children with refractory nephrotic syndrome: a randomized controlled trial. Pediatr Nephrol. 2018 Dec;33(12):2299-2309. doi: 10.1007/s00467-018-4036-x. Epub 2018 Aug 8. |
| Background | McIver, L.A. and Siddique, M.S. (2020). Atorvastatin. [online] Nih.gov. Available at: https://www.ncbi.nlm.nih.gov/books/NBK430779/. |
| 31220048 | Background | Malaker R, Saha S, Hanif M, Ahmed A, Saha S, Hasanuzzaman M, Khondakar T, Islam M, Baqui AH, Santosham M, Darmstadt GL, Whitney CG, Saha SK. Invasive Pneumococcal Infections in Children with Nephrotic Syndrome in Bangladesh. Pediatr Infect Dis J. 2019 Aug;38(8):798-803. doi: 10.1097/INF.0000000000002386. |
| 31830725 | Background | Koskinen JS, Kyto V, Juonala M, Viikari JSA, Nevalainen J, Kahonen M, Lehtimaki T, Hutri-Kahonen N, Laitinen T, Tossavainen P, Jokinen E, Magnussen CG, Raitakari OT. Childhood risk factors and carotid atherosclerotic plaque in adulthood: The Cardiovascular Risk in Young Finns Study. Atherosclerosis. 2020 Jan;293:18-25. doi: 10.1016/j.atherosclerosis.2019.11.029. Epub 2019 Nov 30. |
| FDA (2019). What is a Serious Adverse Event? \[online\] U.S. Food and Drug Administration. | View source |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |