MedTrace Logo

Empaglifozin in Early Diabetic Kidney Disease

NCT03173963 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-02-25

No results posted yet for this study

Summary

Background:

Diabetes is common among American Indian people and diabetic kidney disease is a common complication. Kidney disease caused by diabetes can lead to the need for kidney replacement, by dialysis or kidney transplant, and is also associated with higher risk of early death. A new diabetes medicine called empagliflozin may slow kidney disease from type 2 diabetes. Researchers want to learn if it protects the kidneys when used in very early stages of diabetic kidney disease.

Objectives:

To see if empaglifozin delays kidney disease development.

Eligibility:

Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at least 5 years

Design:

Participants will be screened with health questions, blood pressure, and blood and urine tests.

Participants will have:

* Medical history
* Physical exam
* Blood, urine, and stool samples taken
* Scan of the kidneys and liver. Participants will lie on a table that slides into an MRI machine. They will hold their breath for up to 20 seconds and the MRI machine will take images of their kidneys and liver. They will then repeat this with a small device that vibrates on their side.
* Kidney tests. A needle will be placed in a vein in each arm for 4 hours. Blood pressure will be taken. Participants will drink several quarts of water and urinate every 20 minutes. Urine and blood samples will be collected. Two liquids will be injected into their veins to measure kidney function.
* Photos of the back of the eyes
* Kidney biopsy. Participants will have a scan and get drugs to make them sleepy. Up to four very small pieces of kidney will be removed by needle. After the biopsy participants will be monitored for at least 4 hours.
* Nerve tests

Participants will take the study drug or placebo pill once a day. Participants will attend for tests every twelve weeks and have more extensive kidney function tests once a year. After 3 years, participants will have another kidney biopsy and then stop taking the study drug. They will have a final kidney function test 2 months later.

Conditions

  • Diabetic Kidney Disease
  • Diabetes Mellitus Type 2

Interventions

DRUG

Empagliflozin

10 mg tablet of empagliflozin daily in addition to best clinical practice for management of diabetes.

OTHER

Placebo

1placebo tablet per day

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Helen C Looker · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-27
Primary Completion
2020-02-21
Completion
2020-02-21

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03173963 on ClinicalTrials.gov