drugset / Trial / NCT07497776
Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome
Non-randomizedParallel-groupOpen-labelSupportive care
Summary
To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome.
Timeline
- Start
- 2024-01-27
- Primary completion
- 2025-08-30
- Completion
- 2025-10-31
Publications
- 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].
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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/.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 10 mg | — |