Nephrotic Syndrome in ChildrenPhase 4NCT06417320
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
A Phase 4 study testing ACEI, SGLT-2i in people with Nephrotic Syndrome in Children, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on: 1. Proteinuria 2. Renal survival indices Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Nephrotic Syndrome in Children
- What is being tested?
- ACEI, SGLT-2i
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to Aug 2025
- Phase
- Phase 4
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 10 and 18 years old,
- Nephrotic resistant patients,
- No history of diabetes,
- Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
- Caregivers' acceptance to be enrolled in the study.
Who cannot join
- Uncontrolled urinary tract infection at screening,
- Blood pressure is less than 5th percentile of the same gender, age, height,
- At risk of dehydration or volume depletion,
- Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase >2 times the upper limit of normal during screening,
- History of organ transplantation, cancer, liver disease,
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Children's Hospital
Al Mansurah, Dakahlia Governorate, 35516
Ayman Hammad, MBBCh,MSc,MD, 20502262307, pediatrics@mans.edu.eg
About this study
The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:
- Proteinuria
- Renal survival indices
Read the detailed description
This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.
- Conditions
- Nephrotic Syndrome in Children
- Being tested
- ACEI, SGLT-2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI, SGLT-2iDrug
Also called Captopril, forxiga
Group 1 (ACEI group) will receive a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg) /kg/ day)
❖ Group 2 (combined ACEI and SGLT-2inhibitrs group) patients on a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg /kg/ day) presenting with persistent nephrotic range proteinuria will add a single dose of oral SGLT-2 inhibitors tablets 5mg per day (weight≤30kg) or 10mg per day (weight >30kg)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 (ACEI group) Receives: Drug: ACEI, SGLT-2i |
| Group 2 | Active comparator | Group 2 (combined ACEI and SGLT-2i group) Receives: Drug: ACEI, SGLT-2i |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein free period, eGFR
Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula
Measured: 12 weeks following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jun 2023
- Primary completionJan 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed El Refaey, MBBCh,MSc,MD, Study director, Mansoura University-Faculty of Medicine-Pediatric
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417320
- Sponsor's protocol ID
- MS.22.11.2207
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing of study protocol
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
- ClinicalTrials.gov ID
- NCT06417320
- Acronym / sponsor ID
- MS.22.11.2207
- Conditions
- Nephrotic Syndrome in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 May 2024 (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.
The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:
- Proteinuria
- Renal survival indices
Detailed description
This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: ACEI, SGLT-2iGroup 1 (ACEI group) |
| Group 2 | Active comparator | Drug: ACEI, SGLT-2iGroup 2 (combined ACEI and SGLT-2i group) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 10 and 18 years old,
- Nephrotic resistant patients,
- No history of diabetes,
- Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
- Caregivers' acceptance to be enrolled in the study.
Key exclusion criteria (6 listed)
- Uncontrolled urinary tract infection at screening,
- Blood pressure is less than 5th percentile of the same gender, age, height,
- At risk of dehydration or volume depletion,
- Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase >2 times the upper limit of normal during screening,
- History of organ transplantation, cancer, liver disease,
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 |
|---|---|---|
| ACEI, SGLT-2iAlso: Captopril, forxigaGroup 1 (ACEI group) will receive a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg) /kg/ day) ❖ Group 2 (combined ACEI and SGLT-2inhibitrs group) patients on a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg /kg/ day) presenting with persistent nephrotic range proteinuria will add a single dose of oral SGLT-2 inhibitors tablets 5mg per day (weight≤30kg) or 10mg per day (weight >30kg) | Drug | Group 1, Group 2 |
Primary outcome
Protein free period, eGFR
Time frame: 12 weeks following end of treatment
Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes. sharing of study protocol
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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.
Ahmed El Refaey, MBBCh,MSc,MD study director
Mansoura University-Faculty of Medicine-Pediatric
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACEI, SGLT-2i in people with Nephrotic Syndrome in Children, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Hammad, MBBCh,MSc,MD (+20502262307, pediatrics@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein free period, eGFR (time frame: 12 weeks following end of treatment). 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 16 May 2024.