## Protocol Section
### Identification Module
**NCT ID:** NCT06430684

**Acronym:** SGLT2I-IN-KIDS

**Brief Title:** Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

**Official Title:** Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

#### Organization Study ID Info
**ID:** SGLT2I-IN-KIDS
#### Organization
**Class:** OTHER
**Full Name:** Ann & Robert H Lurie Children's Hospital of Chicago
#### Secondary ID Infos
**ID:** K23DK138313
**Link:** https://reporter.nih.gov/quickSearch/K23DK138313
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

#### Lead Sponsor

**Class:** OTHER

**Name:** Ann & Robert H Lurie Children's Hospital of Chicago

#### Responsible Party

**Investigator Affiliation:** Ann & Robert H Lurie Children's Hospital of Chicago

**Investigator Full Name:** Alexander Kula

**Investigator Title:** Assistant Professor of Pediatrics (Nephrology)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:

1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?

Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.

Study Procedures Include

* For participants randomly selected for treatment, take empagliflozin once daily for 3 months
* Phone calls with researchers every 2 weeks for check-ins
* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests

### Conditions Module

**Conditions:**

- Chronic Kidney Diseases

- Pediatric Kidney Disease

**Keywords:**

- Sodium Glucose Co-Transporter 2 Inhibitor

- SGLT2i

- Pediatric CKD

- Feasibility Study

- Clinical Trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Empagliflozin 10mg daily for 3 months (n=20)

**Intervention Names:**

- Drug: Empagliflozin 10 MG

**Label:** Treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will not take empagliflozin (n=20)

**Label:** Standard of Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment

**Description:** Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older

**Name:** Empagliflozin 10 MG

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Compared to the number recruited, how many participants complete the study

**Measure:** Percentage of participants who complete all study procedures

**Time Frame:** 4 years

#### Secondary Outcomes

**Description:** In-clinic systolic blood pressure

**Measure:** Systolic Blood Pressure

**Time Frame:** 3 months

**Measure:** Serum N-terminal pro-brain natruetic peptide (NT-proBNP)

**Time Frame:** 3 months

**Measure:** Urine Albumin to Creatinine Ratio (UACr)

**Time Frame:** 3 months

**Description:** Measuring using echocardiography

**Measure:** Left Atrial Reservoir Strain

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2

Exclusion Criteria:

* Heart Disease
* Diabetes
* Pregnancy
* Recipient of solid organ transplant
* history of chemotherapy or stem cell transplant
* moderate to severe persistent asthma
* liver disease
* class 2 or greater obesity
* inability to follow study procedures due to cognitive impairment
* obstructive uropathy or requirement for intermittent urinary catheterization
* systolic blood pressure \<100mgHg
* orthostatic hypotension
* current use of an SGLT2i
* anticipated need for titration of anti-hypertensives within 3 months
* active use of any immunosuppressive medications
* lack of clearance by primary nephrologist for participation

**Maximum Age:** 25 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alexkula@luriechildrens.org

**Name:** Alexander J Kula, MD, MHS

**Phone:** 312-227-6160

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chicago

**Contacts:**

***Contact 1:***

- **Email:** alexkula@luriechildrens.org

- **Name:** Alexander J Kula, MD, MHS

- **Phone:** 312-227-6160

- **Role:** CONTACT

**Country:** United States

**Facility:** Ann & Robert H. Lurie Children's Hospital of Chicago

**State:** Illinois

**Zip:** 60611

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- 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: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

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

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M26718

- Name: Renal Insufficiency

- 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: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

### Intervention Browse Module - Ancestors

- ID: D000077203

- Term: Sodium-Glucose Transporter 2 Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M258082

- Name: Empagliflozin

- Relevance: HIGH

- As Found: Part 1

- ID: M1691

- Name: Sodium-Glucose Transporter 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000570240

- Term: Empagliflozin

### Misc Info Module

- Version Holder: 2024-05-31
