A Phase 1 interventional study of Azithromycin and steroids and steroids in Nephrotic Syndrome, sponsored by University of Child Health Sciences and Children's Hospital, Lahore. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by University of Child Health Sciences and Children's Hospital, Lahore · Phase 1, Interventional, and Other
To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome
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.
192 studies on the registry are indexed under Nephrotic Syndrome; 63 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 123 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →University of Child Health Sciences and Children's Hospital, Lahore is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
80 Children will be assigned group A in which children will be given Azithromycin at 10mg /kg/day Per oral along with standard course of treatment.
Drug: Azithromycin and steroids
80 Children will be assigned group B in which children will be only given standard course of steroids.
Drug: steroids
80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.
Also known as: Azithromycin
80 children will be assigned group B and will be given only standard course of treatment
Early remission.
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.
Time frame: 14 days
Relapse reduction
Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids.
Time frame: 14 days
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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University of Child Health Sciences and Children's Hospital, Lahore