## Protocol Section
### Identification Module
**NCT ID:** NCT06417320

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

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

#### Organization Study ID Info
**ID:** MS.22.11.2207
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief 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

**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 Module

**Conditions:**

- Nephrotic Syndrome in Children

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group 1 (ACEI group)

**Intervention Names:**

- Drug: ACEI, SGLT-2i

**Label:** Group 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Group 2 (combined ACEI and SGLT-2i group)

**Intervention Names:**

- Drug: ACEI, SGLT-2i

**Label:** Group 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

- Group 2

**Description:** 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)

**Name:** ACEI, SGLT-2i

**Other Names:**

- Captopril, forxiga

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula

**Measure:** Protein free period, eGFR

**Time Frame:** 12 weeks following end of treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

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 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.

**Maximum Age:** 18 Years

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pediatrics@mans.edu.eg

**Name:** Ayman Hammad, MBBCh,MSc,MD

**Phone:** +20502262307

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mansoura

**Contacts:**

***Contact 1:***

- **Email:** pediatrics@mans.edu.eg

- **Name:** Ayman Hammad, MBBCh,MSc,MD

- **Phone:** 20502262307

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Mansoura University Children's Hospital

**State:** Dakahlia

**Status:** RECRUITING

**Zip:** 35516

#### Overall Officials

**Official 1:**

**Affiliation:** Mansoura University-Faculty of Medicine-Pediatric

**Name:** Ahmed El Refaey, MBBCh,MSc,MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** any one

**Description:** sharing of study protocol

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** 1year

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014555

- Term: Urination Disorders

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020924

- Term: Urological Manifestations

- ID: D000007674

- Term: Kidney Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14368

- Name: Proteinuria

- Relevance: HIGH

- As Found: Proteinuria

- ID: M12349

- Name: Nephrotic Syndrome

- Relevance: HIGH

- As Found: Nephrotic Syndrome

- ID: M12346

- Name: Nephrosis

- Relevance: HIGH

- As Found: Nephrotic Syndrome

- ID: M17305

- Name: Urination Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22659

- Name: Urological Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011507

- Term: Proteinuria

- ID: D000009404

- Term: Nephrotic Syndrome

- ID: D000009401

- Term: Nephrosis

### Intervention Browse Module - Ancestors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000806

- Term: Angiotensin-Converting Enzyme Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000000959

- Term: Antihypertensive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M5476

- Name: Captopril

- Relevance: HIGH

- As Found: Decubitus

- ID: M1691

- Name: Sodium-Glucose Transporter 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4134

- Name: Angiotensin-Converting Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002216

- Term: Captopril

### Misc Info Module

- Version Holder: 2024-05-31
