Diabetic Kidney DiseasePhase 3NCT03173963
Empaglifozin in Early Diabetic Kidney Disease
A Phase 3 study testing Empagliflozin in people with Diabetic Kidney Disease and Diabetes Mellitus Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetic Kidney Disease, Diabetes Mellitus Type 2
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2017to 21 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for participation in the study, participants must meet the following criteria:
- American Indian heritage participants must be at least half American Indian (i.e. 2 out of 4 grand-parents)
- Aged 18-64 years. The lower age limit was set so renal function test results would not reflect changes associated with growth and the upper limit was set to avoid the bladder emptying problems often encountered in older people, since complete bladder emptying is crucial to the accuracy of the renal function measurements done in this study.
- Diagnosis of type 2 diabetes for greater than or equal to 5 years.
- Estimated GFR >60/ml/min as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009) or serum creatinine concentration <1.4 mg/dl in women and <1.5 mg/dl in men.
- Serum potassium concentration less than or equal to 5.5 mEq/L.
Show all 9Show fewer
- A screening urinary albumin-to-creatinine ratio <300 mg/g.
- Willingness to participate after receiving a thorough explanation of the study.
- Participants receiving a RAS blocker must have been receiving the drug for at least 3 months prior to the study baseline examination.
Who cannot join
- Volunteers will be excluded prior to enrollment for the following reasons:
- Clinically significant disorders of the liver [cirrhosis, portal hypertension, hepatitis, increased bilirubin (greater than or equal to 1.5 mg/dl), cardiovascular disease (angina pectoris, history of myocardial infarction, heart failure, cerebrovascular disease, peripheral vascular disease, pulmonary diseases (asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels less than or equal to 30 percent or >55 percent in women or greater than or equal to 35 percent or >60 percent in men.
- Prior treatment with SGLT2 inhibitors.
- Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure greater than or equal to 160 or diastolic greater than or equal to 95 mm Hg) despite treatment with three antihypertensive drugs.
- Hematuria of unknown etiology. Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate.
- Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus (SLE), cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment.
Show all 17Show fewer
- Currently receiving a drug regimen that includes: steroids, immunosuppressants, or investigational new drugs.
- Pregnancy. Boerhinger Ingelheim, the manufacturer of empagliflozin, do not recommend its use during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies or to the intravenous filtration markers iothalamate and para-aminohippurate needed for the renal clearance studies. Women of childbearing potential must have a negative pregnancy test prior to entry and every 3 months during the study, and agree to using an effective form of contraception throughout the study, such as the oral contraceptive pill or an intrauterine device. Women who are planning a pregnancy in the next three years will be excluded.
- Symptoms of inability to empty the bladder. The urinary clearance method is only accurate if complete bladder emptying is possible.
- Hypersensitivity to empagliflozin or iodine.
- Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted, since kidney biopsies cannot be performed safely in these individuals.
- Massive obesity with body mass index greater than or equal to 45 kg/m(2). Kidney biopsies are more difficult and present greater hazards to people with massive obesity.
- Allergy to iodine-containing contrast material.
- Non-diabetic kidney disease based on clinical history or kidney biopsy examination.
- History of severe recurrent kidney infections.
- History of osteoporotic fracture.
- Conditions likely to interfere with informed consent or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empagliflozin in Early Diabetic Kidney Disease
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.
Read more
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.
Read the detailed description
The purpose of this protocol is to examine the effects of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin on kidney disease progression in American Indians with type 2 diabetes and early diabetic kidney disease (DKD) via a double-blinded placebo-controlled clinical trial. This trial will enroll 100 participants who will be randomly assigned to receive either 10 mg of empagliflozin or placebo daily for three years in addition to standard of care. Participants will be followed quarterly to monitor their health, identify any adverse effects of treatment, and to assess their adherence to therapy. The primary objective of this study is to determine whether empagliflozin affects structural and functional progression of DKD in American Indians with type 2 diabetes and early DKD to a greater extent than standard diabetes care alone, which may include treatment with renin-angiotensin system (RAS) blockers. The primary outcome measure will be a change in cortical interstitial fractional volume [Vv(Int/cortex)] as assessed by morphometric examination of kidney biopsy specimens obtained at study entry and after the three years of study drug treatment. Secondary outcomes include an effect of empagliflozin on kidney function including measures of glomerular filtration rate and renal plasma flow, and effects on other kidney biopsy morphometric measurements. Biopsy tissue will also be used for gene expression studies and for epigenetic profiling. Magnetic resonance imaging of the kidneys will be performed prior to each biopsy to correlate the structural damage seen at kidney biopsy with the level of fibrosis detected by imaging. In addition to annual renal clearance studies we will conduct a series of other tests at each renal clearance visit. These will include tests of cognitive function and of the peripheral and autonomic nervous system to determine the frequency, severity, and rate of progression of diabetic neuropathy in this cohort and identify linkages between DKD and diabetic neuropathy, and retinal photographs to assess diabetic retinopathy status and its linkage with DKD. The effect of treatment with empagliflozin on the development and progression of neuropathy and retinopathy will also be assessed. To assess acute effects of empagliflozin on renal function at the commencement and cessation of the drug we will undertake additional renal clearance studies two weeks after enrollment and two months after discontinuation of the drug. A small punch skin biopsy may be performed for assessment of intraepidermal nerve fiber density or for fibroblast culture. The skin biopsy for fibroblast culture will be done only once unless the culture fails, in which case the patient may be invited to undergo another biopsy. We may invite participants to undergo skin biopsy on several occassions for assessment of changes in nerve fiber density. We may also perform magnetic resonance imaging of the kidneys or the brain in some participants. Imaging of the kidneys will be done as near to the time of each kidney biopsy as possible. We may invite participants to undergo the brain imaging at the beginning and end of the study. Participants will be followed annually after completion of the clinical trial until death or development of end-stage renal disease.
- Conditions
- Diabetic Kidney Disease, Diabetes Mellitus Type 2
- Being tested
- Empagliflozin, Placebo
- Keywords
- Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor, Kidney Biopsy, Morphometry, American Indians, Glomerular Filtration Rate
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
10 mg tablet of empagliflozin daily in addition to best clinical practice for management of diabetes.
PlaceboOther
1placebo tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Drug | Active comparator | Empagliflozin 10mg once a day Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | 1 placebo tablet a day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of empagliflozin on change in cortical interstitial fractional volume [Vv(Int/cortex) over the 3-year study period.
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.
Measured: 3 years
Secondary outcomes (3)
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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start27 May 2017
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Why it stopped: Original drug sponsor withdrew from study, replacement sponsor not obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Helen C Looker, Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173963
- Sponsor's protocol ID
- 999917103
- Other IDs
- 17-DK-N103
- Status last verified
- Feb 2020
- First submitted
- 27 May 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.
PubMed 27299675Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978Cordonnier DJ, Pinel N, Barro C, Maynard M, Zaoui P, Halimi S, Hurault de Ligny B, Reznic Y, Simon D, Bilous RW. Expansion of cortical interstitium is limited by converting enzyme inhibition in type 2 diabetic patients with glomerulosclerosis. The Diabiopsies Group. J Am Soc Nephrol. 1999 Jun;10(6):1253-63. doi: 10.1681/ASN.V1061253.
PubMed 10361863
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin in Early Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT03173963
- Acronym / sponsor ID
- 999917103
- Conditions
- Diabetic Kidney Disease, Diabetes Mellitus Type 2
- Keywords
- Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor, Kidney Biopsy, Morphometry, American Indians, Glomerular Filtration Rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original drug sponsor withdrew from study, replacement sponsor not obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 May 2017 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this protocol is to examine the effects of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin on kidney disease progression in American Indians with type 2 diabetes and early diabetic kidney disease (DKD) via a double-blinded placebo-controlled clinical trial. This trial will enroll 100 participants who will be randomly assigned to receive either 10 mg of empagliflozin or placebo daily for three years in addition to standard of care. Participants will be followed quarterly to monitor their health, identify any adverse effects of treatment, and to assess their adherence to therapy. The primary objective of this study is to determine whether empagliflozin affects structural and functional progression of DKD in American Indians with type 2 diabetes and early DKD to a greater extent than standard diabetes care alone, which may include treatment with renin-angiotensin system (RAS) blockers. The primary outcome measure will be a change in cortical interstitial fractional volume [Vv(Int/cortex)] as assessed by morphometric examination of kidney biopsy specimens obtained at study entry and after the three years of study drug treatment. Secondary outcomes include an effect of empagliflozin on kidney function including measures of glomerular filtration rate and renal plasma flow, and effects on other kidney biopsy morphometric measurements. Biopsy tissue will also be used for gene expression studies and for epigenetic profiling. Magnetic resonance imaging of the kidneys will be performed prior to each biopsy to correlate the structural damage seen at kidney biopsy with the level of fibrosis detected by imaging. In addition to annual renal clearance studies we will conduct a series of other tests at each renal clearance visit. These will include tests of cognitive function and of the peripheral and autonomic nervous system to determine the frequency, severity, and rate of progression of diabetic neuropathy in this cohort and identify linkages between DKD and diabetic neuropathy, and retinal photographs to assess diabetic retinopathy status and its linkage with DKD. The effect of treatment with empagliflozin on the development and progression of neuropathy and retinopathy will also be assessed. To assess acute effects of empagliflozin on renal function at the commencement and cessation of the drug we will undertake additional renal clearance studies two weeks after enrollment and two months after discontinuation of the drug. A small punch skin biopsy may be performed for assessment of intraepidermal nerve fiber density or for fibroblast culture. The skin biopsy for fibroblast culture will be done only once unless the culture fails, in which case the patient may be invited to undergo another biopsy. We may invite participants to undergo skin biopsy on several occassions for assessment of changes in nerve fiber density. We may also perform magnetic resonance imaging of the kidneys or the brain in some participants. Imaging of the kidneys will be done as near to the time of each kidney biopsy as possible. We may invite participants to undergo the brain imaging at the beginning and end of the study. Participants will be followed annually after completion of the clinical trial until death or development of end-stage renal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Active comparator | Drug: EmpagliflozinEmpagliflozin 10mg once a day |
| Placebo | Placebo comparator | Other: Placebo1 placebo tablet a day |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- To be eligible for participation in the study, participants must meet the following criteria:
- American Indian heritage participants must be at least half American Indian (i.e. 2 out of 4 grand-parents)
- Aged 18-64 years. The lower age limit was set so renal function test results would not reflect changes associated with growth and the upper limit was set to avoid the bladder emptying problems often encountered in older people, since complete bladder emptying is crucial to the accuracy of the renal function measurements done in this study.
- Diagnosis of type 2 diabetes for greater than or equal to 5 years.
- Estimated GFR >60/ml/min as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009) or serum creatinine concentration <1.4 mg/dl in women and <1.5 mg/dl in men.
Key exclusion criteria (17 listed)
- Clinically significant disorders of the liver [cirrhosis, portal hypertension, hepatitis, increased bilirubin (greater than or equal to 1.5 mg/dl), cardiovascular disease (angina pectoris, history of myocardial infarction, heart failure, cerebrovascular disease, peripheral vascular disease, pulmonary diseases (asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels less than or equal to 30 percent or >55 percent in women or greater than or equal to 35 percent or >60 percent in men.
- Prior treatment with SGLT2 inhibitors.
- Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure greater than or equal to 160 or diastolic greater than or equal to 95 mm Hg) despite treatment with three antihypertensive drugs.
- Hematuria of unknown etiology. Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate.
- Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus (SLE), cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin10 mg tablet of empagliflozin daily in addition to best clinical practice for management of diabetes. | Drug | Drug |
| Placebo1placebo tablet per day | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
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 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 27299675Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.
- Background: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Background: PubMed 10361863Cordonnier DJ, Pinel N, Barro C, Maynard M, Zaoui P, Halimi S, Hurault de Ligny B, Reznic Y, Simon D, Bilous RW. Expansion of cortical interstitium is limited by converting enzyme inhibition in type 2 diabetic patients with glomerulosclerosis. The Diabiopsies Group. J Am Soc Nephrol. 1999 Jun;10(6):1253-63. doi: 10.1681/ASN.V1061253.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen C Looker principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin in people with Diabetic Kidney Disease and Diabetes Mellitus Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.