Empaglifozin in Early Diabetic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03173963|
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : February 19, 2018
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.
To see if empaglifozin delays kidney disease development.
Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at least 5 years
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Kidney Disease Diabetes Mellitus Type 2||Drug: Empagliflozin Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Empagliflozin in Early Diabetic Kidney Disease|
|Anticipated Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Active Comparator: Drug
Empagliflozin 10mg once a day
10 mg tablet of empagliflozin daily in addition to best clinical practice for management of diabetes.
Placebo Comparator: Placebo
1 placebo tablet a day
1placebo tablet per day
- Effect of empagliflozin on change in cortical interstitial fractional volume [Vv(Int/cortex) over the 3-year study period. [ Time Frame: 3 years ]
- Effect of empagliflozin on changes in total interstitium per cortex per kidney, mesangial fractional volume, glomerular basement membrane width, glomerular filtration surface density, and total filtration surface per glomerulus. [ Time Frame: 3 years ]
- Effect of empagliflozin on changes in podocyte numerical density, podocyte number per glomerulus, podocyte foot process width, percentage podocyte detachment, and percentage glomerular endothelial cell fenestration. [ Time Frame: 3 years ]
- Effect of empagliflozin on incidence of >40% decline in GFR from baseline, increase in urinary albumin excretion from baseline, progression to ESRD, or death. [ Time Frame: 3 years ]
- Effect of empagliflozin on development or progression of diabetic retinopathy determined by changes from baseline to 3 years of at least 2 Early Treatment of Diabetic Retinopathy Study levels in grading of standardized retinal photographs. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173963
|Contact: Helen C Looker||(602) firstname.lastname@example.org|
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|Contact: Helen Looker 602-200-5215 email@example.com|
|Principal Investigator:||Helen C Looker||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|