ClinicalTrials.gg
RecruitingNCT06417320Updated May 16, 2024

Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years

A Phase 4 interventional study of ACEI, SGLT-2i in Nephrotic Syndrome in Children, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Mansoura University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Jun 2023, registered May 2024).
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Nephrotic Syndrome with a site in Egypt — 5 open to participants now, 6 under way, 1 of them phase 3. Nephrotic Syndrome · Egypt.

Started
2023
with 1 other
Phase 4
3 of 10
2 open now
Registered
6th of 10
by date
Lead sponsor
3 of 10
Mansoura University

Among the 10 studies in Nephrotic Syndrome with a site in Egypt, this one is one of 2 that started in 2023, is one of 3 in phase 4, and was the 6th registered.

Nephrotic Syndrome

191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.

Browse Nephrotic Syndrome studies →

Open to participants now

5 of the 10 studies in Nephrotic Syndrome with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.

This study: 10 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Nephrotic Syndrome with a site in Egypt, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Nephrotic Syndrome in Children

Browse trials for

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 10 and 18 years old,
  • Nephrotic resistant patients,
  • No history of diabetes,
  • Estimated ≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
  • Caregivers' acceptance to be enrolled in the study.

Exclusion criteria

Exclusion Criteria:

  • 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 or aspartate transaminase >2 times the during screening,
  • History of organ transplantation, cancer, liver disease,
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group 1

    Group 1 (ACEI group)

    Drug: ACEI, SGLT-2i

  • Active comparator
    Group 2

    Group 2 (combined ACEI and SGLT-2i group)

    Drug: ACEI, SGLT-2i

Interventions

  • DrugACEI, SGLT-2i

    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)

    Also known as: Captopril, forxiga

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks following end of treatment

07

Study locations

1 of 1 sites recruiting
  • Mansoura University Children's Hospital
    Mansoura, Dakahlia 35516, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — sharing of study protocol

Supporting information: Study protocol

Time frame: 1year

Access criteria: any one

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Jan 2025, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2024
First posted
May 16, 2024
StartActual
Jun 1, 2023
Primary completionEst.
Jan 2025
CompletionEst.
Aug 2025
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06417320
Responsible party
Sponsor
First posted
May 16, 2024
Start date
Jun 1, 2023
Primary completion
Jan 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
May 16, 2024

Study contacts

Ayman Hammad, MBBCh,MSc,MD
Contact
pediatrics@mans.edu.eg
+20502262307
Ahmed El Refaey, MBBCh,MSc,MD
study director · Mansoura University-Faculty of Medicine-Pediatric

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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