Empaglifozin in Early Diabetic Kidney Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT03173963
Phase
PHASE3
Status
Withdrawn

Conditions

  • Diabetes Mellitus Type 2
  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    10 mg tablet of empagliflozin daily in addition to best clinical practice for management of diabetes.
  • Placebo — OTHER
    1placebo tablet per day

Study Details

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.

Key Dates

Start date
May 27, 2017
Status verified
Feb 2020
Primary completion
Feb 21, 2020
Completion
Feb 21, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Drug
    Empagliflozin 10mg once a day
  • Placebo Comparator: Placebo
    1 placebo tablet a day

Primary Outcome Measure

Effect of empagliflozin on change in cortical interstitial fractional volume [Vv(Int/cortex) over the 3-year study period. [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
NIDDK, PhoenixPhoenixArizona85014-

Find similar trials in Phoenix, AZ

By research site
NIDDK, Phoenix· Phoenix, AZ

Related Studies