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

NCT07320612 | Completed Phase 1 DMC

• 1 other identifier: 08-03-2025Approved by UCHS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (1)

• Relapse reduction

  14 days

Study Arms (2)

Group taking Azithromycin and Steroids

EXPERIMENTAL

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

Group Taking steroids

ACTIVE COMPARATOR

80 Children will be assigned group B in which children will be only given standard course of steroids.

Drug: steroids

Interventions

Azithromycin and steroids DRUG

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

Also known as: Azithromycin

Group taking Azithromycin and Steroids

steroids DRUG

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

Group Taking steroids

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

UCHS

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Azithromycin; Steroids

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr. Ummara Subhani, MD

  UCHS Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 6, 2026
• Study Start: March 8, 2025
• Primary Completion: August 8, 2025
• Study Completion: October 8, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-11

Locations

PA (1)