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SGLT2 Inhibitor

Empagliflozin for Chronic Kidney Disease (NDKD Trial)

Phase 4
Recruiting
Led By Sabyasachi Sen, MD
Research Sponsored by Washington D.C. Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

NDKD Trial Summary

This trial aims to investigate specific kidney injury markers in African American Veterans with non-diabetic kidney disease who are taking empagliflozin. The main focus is on studying the effect of empag

Who is the study for?
This trial is for African American veterans aged 20-90 with non-diabetic chronic kidney disease, specifically those who have a BMI of 25-45 and controlled blood pressure. They must have an eGFR between 30-90 mL/min/1.73 m2, albuminuria of at least 30 mg/g, and HbA1C levels below 6.5%. Participants need to be able to give informed consent.Check my eligibility
What is being tested?
The study tests the effect of Empagliflozin on proteins indicating podocyte injury in urine exosomes versus a placebo. It aims to see if this drug can improve markers related to kidney damage in patients without diabetes by comparing it with standard biomarkers like ACR and estimated GFR.See study design
What are the potential side effects?
Empagliflozin may cause side effects such as urinary tract infections, dehydration leading to low blood pressure, ketoacidosis (a serious condition where the body produces high levels of blood acids called ketones), genital yeast infections, and increased cholesterol.

NDKD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To study kidney dysfunction and podocyte specific injury
Secondary outcome measures
Systemic inflammatory markers

NDKD Trial Design

2Treatment groups
Active Control
Group I: PlaceboActive Control1 Intervention
Placebo 10 mg orally daily
Group II: EmpagliflozinActive Control1 Intervention
Empagliflozin 10 mg orally daily

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor
2,509 Previous Clinical Trials
11,340,955 Total Patients Enrolled
Washington D.C. Veterans Affairs Medical CenterLead Sponsor
39 Previous Clinical Trials
17,977 Total Patients Enrolled
Sabyasachi Sen, MDPrincipal InvestigatorWashington VA Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 35 years eligible to participate in this research trial?

"Eligible participants for this research effort must fall within the age range of 19 to 90 years. Notably, there are a total of 48 investigations tailored towards individuals below 18 years old and 496 studies focused on patients aged over 65."

Answered by AI

What are the potential risks associated with Empagliflozin for individuals?

"The safety rating assigned to Empagliflozin by our team at Power is 3, reflecting the advanced phase of this trial (Phase 4), which signifies approval for this treatment."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this study?

"For this trial, the investigators seek to enroll 60 individuals with chronic kidney disease aged between 19 and 90 years. Essential requirements include: age ranging from 20 to 90 years old, BMI falling within the range of 25-45, being of African American descent, having an estimated glomerular filtration rate (eGFR) between ≥30-90 mL/min/1.73 m2 as calculated by CKD-EPI equation, albuminuria levels equal to or exceeding 30 mg/g during screening, maintaining blood pressure under control at ≤140/90 mmHg while on a consistent antihypert"

Answered by AI

How many participants in total are involved in this research investigation?

"Indeed, the information available on clinicaltrials.gov highlights that this specific trial is in an active recruitment phase. Originally shared on February 2nd, 2024, and last modified on April 10th of the same year, the trial aims to enroll a total of 60 participants from a single site."

Answered by AI

Are individuals currently eligible to apply for participation in this ongoing medical study?

"Affirmative. Information found on clinicaltrials.gov indicates that this study is presently in search of participants. Originally listed on February 2nd, 2024, the trial's most recent update was on April 10th, 2024. A total of 60 individuals are sought for enrollment at a singular site."

Answered by AI
~40 spots leftby Dec 2025