DyslipidaemiaPhase 4NCT07497776

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

A Phase 4 study testing Atorvastatin in people with Dyslipidaemia, run by National Institute of Kidney Disease and Urology (NIKDU) at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the effectiveness and safety of Atorvastatin therapy in children with dyslipidemia in steroid sensitive nephrotic syndrome. Read more about this study

Who is it for?: Ages 8 to 18 years
Conditions the study is for: Dyslipidaemia
What is being tested?: Atorvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteBangladesh
Study dates: 27 Jan 2024to 31 Oct 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Bangladesh1 site

National Institute of kidney diseases and Urology
Dhaka, Dhaka Division, 1207

Other trials in Bangladesh

About this study

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

Read the detailed 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.

Conditions: Dyslipidaemia
Being tested: Atorvastatin
Keywords: Steroid sensitive nephrotic syndrome, Dyslipidemia, Atorvastatin
Medical subject headings: Dyslipidemias, Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtorvastatinDrug
Also called Atova/Lipitor
Atorvastatin 10 mg nightly dose

Study groups in NCT07497776
Study group	Role	What they receive
Control arm/Placebo arm	No intervention	Dietary Advice
Intervention arm/ Atorvastatin	Experimental	Dietary advice plus atorvastatin Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 202431 Oct 2025

First posted27 Mar 2026
Study start27 Jan 2024
Primary completion30 Aug 2025
Study completion31 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for DyslipidaemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: This quasi-experimental study
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07497776
Sponsor's protocol ID: NIKDU-Bangla
Status last verified: Mar 2026
First submitted: 13 Mar 2026
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data mangement and renrollment analysis and results

Publications

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].
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.
PubMed 34556300
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.
PubMed 40254391
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.
PubMed 36494853
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.
PubMed 38319465
Bagga , A. and Srivastava, R. (2025). Pediatric Nephrology. 7th ed. New Delhi, India: Jaypee Brothers Medical Publishers, pp.266-289.
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.
PubMed 36269406
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.
PubMed 27165836
Yap, H.-K., Teo, S., Lu, L. and Ng, K.-H. (2024). Pediatric Nephrology On-The-Go. 5th ed. Singapore: World Scientific Publishing Company.
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.
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.
PubMed 31302760
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.
PubMed 30091061
McIver, L.A. and Siddique, M.S. (2020). Atorvastatin. [online] Nih.gov. Available at: https://www.ncbi.nlm.nih.gov/books/NBK430779/.
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.
PubMed 31220048
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.
PubMed 31830725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome
ClinicalTrials.gov ID: NCT07497776
Acronym / sponsor ID: NIKDU-Bangla
Conditions: Dyslipidaemia
Keywords: Steroid sensitive nephrotic syndrome, Dyslipidemia, Atorvastatin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: National Institute of Kidney Disease and Urology (NIKDU)University, hospital or other
Study start: 27 Jan 2024 (actual)
Primary completion: 30 Aug 2025 (actual)
Study completion: 31 Oct 2025 (actual)
First posted: 27 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This quasi-experimental study

Arm	Type	Receives
Control arm/Placebo arm	No intervention	–Dietary Advice
Intervention arm/ Atorvastatin	Experimental	Drug: AtorvastatinDietary advice plus atorvastatin

Who may qualify

Ages: 8 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtorvastatinAlso: Atova/LipitorAtorvastatin 10 mg nightly dose	Drug	Intervention arm/ Atorvastatin

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
BackgroundRoy, 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: PubMed 34556300Rovin 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: PubMed 40254391Kidney 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: PubMed 36494853Kamel 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: PubMed 38319465Carboni 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.
BackgroundBagga , A. and Srivastava, R. (2025). Pediatric Nephrology. 7th ed. New Delhi, India: Jaypee Brothers Medical Publishers, pp.266-289.
Background: PubMed 36269406Trautmann 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: PubMed 27165836Vaziri 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.
BackgroundYap, H.-K., Teo, S., Lu, L. and Ng, K.-H. (2024). Pediatric Nephrology On-The-Go. 5th ed. Singapore: World Scientific Publishing Company.
BackgroundHoque, 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: PubMed 31302760Hari 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: PubMed 30091061Hari 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.
Centers for Disease Control and Prevention (2024). Child and Teen BMI Categories. \[online\] BMI.Link provided by the sponsor.
FDA (2019). What is a Serious Adverse Event? \[online\] U.S. Food and Drug Administration.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Data mangement and renrollment analysis and results

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Saieef Zaman, MD principal investigator

National institute of kidney Disease & Urology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin in people with Dyslipidaemia, run by National Institute of Kidney Disease and Urology (NIKDU) at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of patients achieving target levels of lipid profile (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497776, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.