Empaglifozin in Early Diabetic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03173963|
Recruitment Status : Not yet recruiting
First Posted : June 2, 2017
Last Update Posted : October 18, 2019
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|
|Estimated Study Start Date :||October 23, 2019|
|Estimated Primary Completion Date :||August 4, 2024|
|Estimated Study Completion Date :||August 4, 2024|
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 ]Cortical interstitial fractional volume is a measure of the proportion of kidney cortex made up of interstitium. The measurement is made using light microscopy images of kidney tissue. It is positively associated with progression of diabetic kidney disease and is the glomerular measurement that changes most dramatically over time in diabetic kidney disease. We will compare change in cortical interstitial fractional volume from baseline to 3-year biopsy in the group randomized to Empagliflozin and the group randomized to placebo.
- 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 ]Changes in total interstitial volume (calculated from the cortical interstitial fractional volume and cortical volume assessed by MRI) along with key glomerular morphometric measurements (mesangial fractional volume, glomerular basement membrane width, glomerular filtration surface density, and total filtration surface per glomerulus) assessed using electron microscopy images, are all associated with progression of diabetic kidney disease. We will compare change in total cortical interstitial volume and other glomerular measures from baseline to 3-year biopsy in the group randomized to Empagliflozin and the group randomized to placebo.
- 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 ]As diabetic kidney disease progresses podocytes are lost, and the barrier made up of podocyte foot processes and endothelial cell fenestrations becomes more porous. We will compare change in these podocyte measures from baseline to 3-year biopsy in the group randomized to Empagliflozin and the group randomized to placebo.
- 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 ]Diabetic retinopathy is another microvascular complication of diabetes and untreated can lead to loss of sight. Diabetic retinopathy is detected and staged using digital retinal photography. We will test for effects of Empagliflozin treatment on the incidence of new retinopathy and the progression of existing retinopathy from baseline to 3- years in the group randomized to Empagliflozin and the group randomized to placebo.
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) email@example.com|
|United States, Arizona|
|NIDDK, Phoenix||Not yet recruiting|
|Phoenix, Arizona, United States, 85014|
|Contact: Helen Looker 602-200-5215 firstname.lastname@example.org|
|Principal Investigator:||Helen C Looker||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|