Recruiting EARLY_PHASE1 Chronic Kidney Diseases

New treatment option for Chronic Kidney Diseases

Official title Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

ClinicalTrials.gov ID: NCT06430684

What this study is testing

What is Empagliflozin 10 MG?

Empagliflozin 10 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic kidney diseases.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 to 25

You may be able to join if

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

You likely can't join if

  • Heart Disease
  • Diabetes
  • Pregnancy
  • Recipient of solid organ transplant
  • history of chemotherapy or stem cell transplant
  • moderate to severe persistent asthma
See the full eligibility criteria
Who can join
  • Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years to 25 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.