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OpenTrials
Completed

NCT Number: NCT07320612

Efficacy And Safety Of Azithromycin To Achieve Remissionin In Children With Steroid Sensitive Nephrotic Syndrome

To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCHS

Lahore, Punjab Province, 54600, Pakistan

About this study

It is a randomized controlled trial. Total 160 children meeting inclusion criteria will be included in the study. Selected children will be divided into 2 groups. one group will be given Azithromycin at 10mg/kg/day (1 dose per day) for 3 days along with standard course of steroids. 2nd group will be given standard course of treatment. All patients will be followed up for 1 month and remission will be noted. All data will be collected through specially designed performa. Patient's safety and Efficacy of drug in Achieving early Remission will be closely monitored.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children age 2 to 14 years
  • Both genders
  • Children having primary nephrotic syndrome

Exclusion criteria

  • Children with steroid resistant nephrotic syndrome
  • Children with secondary causes of nephrotic syndrome
  • Recent use of azithromycin during last 4 weeks
  • Severe systemic infection requiring antibiotics
  • Chronic liver disease Prolong QT Interval or history of cardiac arythmias

Treatment and study plan

Azithromycin and steroids

Drug

80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.

Other names: Azithromycin

Steroids

Drug

80 children will be assigned group B and will be given only standard course of treatment

Primary outcomes

  1. Early remission.

    Time frame: 14 days

    This study will make an impact on understanding the effectiveness and safety of azithromycin in children regain early remission. It will be classified as either complete or partial remission. Complete remission will be indicated as negative or having trace proteinuria and will be measured with the help of early morning urine dipstick test for proteinuria for 3 consecutive days, serum albumin level of more than 2.5g/dl and resolution of edema. Partial remission will be defined as serum albumin level of more than 2.5g/dl but with persistent proteinuria. Early Remission and relapse will be presented as frequency and percentage. Both groups will be compared for early remission by chi square test.

Secondary outcomes

  1. Relapse reduction

    Time frame: 14 days

    Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids.

Sponsors and collaborators

Lead sponsor

University of Child Health Sciences and Children's Hospital, Lahore

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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