NCT07497776

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 13, 2026

Last Update Submit

March 23, 2026

Conditions

Dyslipidaemia

Keywords

Steroid sensitive nephrotic syndromeDyslipidemiaAtorvastatin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control arm/Placebo arm

NO INTERVENTION

Dietary Advice

Intervention arm/ Atorvastatin

EXPERIMENTAL

Dietary advice plus atorvastatin

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Atorvastatin 10 mg nightly dose

Also known as: Atova/Lipitor
Intervention arm/ Atorvastatin

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of kidney diseases and Urology

Dhaka, Dhaka Division, 1207, Bangladesh

Location

Related Publications (15)

  • 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, B.H. et al. (2021) 'Executive summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases,' Kidney International, 100(4), pp. 753-779. https://doi.org/10.1016/j.kint.2021.05.015.

    BACKGROUND

  • Kidney Disease: Improving Global Outcomes (KDIGO) Nephrotic Syndrome in Children Work Group. KDIGO 2025 Clinical Practice Guideline for the Management of Nephrotic Syndrome in Children. Kidney Int. 2025;107(5S): S241-S289.

    BACKGROUND

  • Kamel, A.S. et al. (2022) 'Evaluation of carotid intima media thickness in children with idiopathic nephrotic syndrome,' the Italian Journal of Pediatrics/Italian Journal of Pediatrics, 48(1). https://doi.org/10.1186/s13052-022-01383-7.

    BACKGROUND

  • Carboni, J. et al. (2024) 'Longitudinal analysis of blood pressure and lipids in childhood nephrotic syndrome,' Pediatric Nephrology, 39(7), pp. 2161-2170. https://doi.org/10.1007/s00467-024-06301-z.

    BACKGROUND

  • Bagga , A. and Srivastava, R. (2025). Pediatric Nephrology. 7th ed. New Delhi, India: Jaypee Brothers Medical Publishers, pp.266-289.

    BACKGROUND

  • Trautmann, A. et al. (2022) 'IPNA clinical practice recommendations for the diagnosis and management of children with steroid-sensitive nephrotic syndrome,' Pediatric Nephrology, 38(3), pp. 877-919. https://doi.org/10.1007/s00467-022-05739-3.

    BACKGROUND

  • Vaziri, N.D. (2016). Disorders of Lipid Metabolism in Nephrotic syndrome: Mechanisms and Consequences. Kidney International, 90(1), pp.41-52. doi:https://doi.org/10.1016/j.kint.2016.02.026.

    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. and Smoyer, W.E. (2019). Dyslipidemia and cardiovascular health in childhood nephrotic syndrome. Pediatric Nephrology, 35(9), pp.1601-1619. doi:https://doi.org/10.1007/s00467-019-04301-y.

    BACKGROUND

  • Hari, P. et al. (2018) 'Effect of atorvastatin on dyslipidemia and carotid intima-media thickness in children with refractory nephrotic syndrome: a randomized controlled trial,' Pediatric Nephrology, 33(12), pp. 2299-2309. https://doi.org/10.1007/s00467- 018-4036-x.

    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. et al. (2019) 'Invasive Pneumococcal Infections in Children with Nephrotic Syndrome in Bangladesh, ' The Pediatric Infectious Disease Journal, 38(8), pp. 798- 803.

    BACKGROUND

  • Koskinen, J.S. et al. (2019) 'Childhood risk factors and carotid atherosclerotic plaque in adulthood: The Cardiovascular Risk in Young Finns Study, ' Atherosclerosis, 293, pp. 18-25. https://doi.org/10.1016/j.atherosclerosis.2019.11.029

    BACKGROUND

Related Links

MeSH Terms

Conditions

DyslipidemiasNephrotic Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Saieef Zaman, MD

    National institute of kidney Disease & Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 27, 2026

Study Start

January 27, 2024

Primary Completion

August 30, 2025

Study Completion

October 31, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data mangement and renrollment analysis and results

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
27/01/2024 to 31/03/2026
Access Criteria
Who : Researchers, What : Results and Data, How : Publication, Correspondent person
More information

Locations

BA(1)