Nephrotic SyndromePhase 1NCT07320612
Efficacy And Safety Of Azithromycin To Achieve Remissionin In Children With Steroid Sensitive Nephrotic Syndrome
A Phase 1 study testing Azithromycin and steroids and steroids in people with Nephrotic Syndrome, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial summary
To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Azithromycin and steroids and steroids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Mar 2025to 8 Oct 2025
- Phase
- Phase 1
- 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 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age 2 to 14 years
- Both genders
- Children having primary nephrotic syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome
Read the detailed description
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.
- Conditions
- Nephrotic Syndrome
- Being tested
- Azithromycin and steroids, steroids
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin and steroidsDrug
Also called Azithromycin
80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.
steroidsDrug
80 children will be assigned group B and will be given only standard course of treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (1)
Relapse reduction
Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start8 Mar 2025
- Primary completion8 Aug 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ummara Subhani, University of Child Health Sciences and Children's Hospital, Lahore
- Investigators
- Dr. Ummara Subhani, MD, Principal investigator, UCHS Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320612
- Sponsor's protocol ID
- 08-03-2025Approved by UCHS
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of Azithromycin To Achieve Remissionin In Children With Steroid Sensitive Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT07320612
- Acronym / sponsor ID
- 08-03-2025Approved by UCHS
- Conditions
- Nephrotic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 6 Jan 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 compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group taking Azithromycin and Steroids | Experimental | Drug: Azithromycin and steroids80 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. |
| Group Taking steroids | Active comparator | Drug: steroids80 Children will be assigned group B in which children will be only given standard course of steroids. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children age 2 to 14 years
- Both genders
- Children having primary nephrotic syndrome
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Azithromycin and steroidsAlso: Azithromycin80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids. | Drug | Group taking Azithromycin and Steroids |
| steroids80 children will be assigned group B and will be given only standard course of treatment | Drug | Group Taking steroids |
Primary outcome
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.
1 secondary outcome
Relapse reduction
Time frame: 14 days
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 6 Jan 2026.
Related trials for Nephrotic Syndrome
Active, not recruitingPhase 2/3
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
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Effects of Meal Macronutrients on Postprandial Lipids
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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.
Dr. Ummara Subhani, MD principal investigator
UCHS Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin and steroids and steroids in people with Nephrotic Syndrome, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
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 3 inclusion and 5 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 6 Jan 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 Pakistan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Early remission. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.