Diabetic Kidney DiseasePhase 2EMPRANCT03078101
EMPRA (EMPagliflozin and RAs in Kidney Disease)
A Phase 2 study testing Empagliflozin 10 MG [Jardiance] in people with Diabetic Kidney Disease and Diabetes Mellitus, Type 2, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study will be a prospective, clinical pilot study in CKD patients to show whether Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Diabetes Mellitus, Type 2, Chronic Kidney Disease stage3
- What is being tested?
- Empagliflozin 10 MG [Jardiance]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteAustria
- Study dates
- 15 Apr 2017to 7 Aug 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- for CKD patients with type 2 diabetes
- Estimated GFR (calculated with the MDRD-IDMS formula) between 15 and 59 ml/min (with CKD stage IIIa/b to IV)
- Albumin excretion rates of 30-300 mg/24 hours (UACR <300 mg/g)
- Fasting plasma glucose levels >126 mg/dl [7mmol/L] or HbA1c levels >6.5% (Definition of type 2 diabetes according to the diagnostic criteria set forth by the American Diabetes Association in 2009)
- for CKD patients without Diabetes
- Estimated GFR (calculated with the MDRD-IDMS formula) between 15 and 59 ml/min (with CKD stage IIIa/b to IV)
- Albumin excretion rates of 30-300 mg/24 hours (UACR <300 mg/g)
Who cannot join
- CKD patients with type 2 diabetes
- Age <18 years
- Severely impaired renal function (eGFR <15ml/min)
- Hyperkalemia above 4.5mmol/L
- Hypotension (systolic blood pressure lower than 120 mmHg on ambulatory measurement)
- Pregnant patients
Show all 16Show fewer
- Patients planning pregnancy
- Body mass index < 18.5 kg/m2
- for CKD patients without diabetes
- Age <18 years
- Diabetic kidney disease
- Severely impaired renal function (eGFR <15ml/min)
- Hypotension (systolic blood pressure lower than 120 mmHg on ambulatory measurement)
- Pregnant patients
- Patients planning pregnancy
- Body mass index < 18.5 kg/m2 -
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
Vienna, 1090
About this study
Official title: Effect of Empagliflozin on the Renin-angiotensin System in Patients With Chronic
This study will be a prospective, clinical pilot study in CKD patients to show whether Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone.
Null and alternative hypotheses:
Read more
H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than ACEi treatment alone.
H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone
Methodology:
Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2 diabetes will be randomized into the study medication or placebo group. The number of patients per treatment arms is n = 12. Included and consented patients will be subjected to an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following the 2-week run-in phase, all study patients will be subjected to blood collection including the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently, patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and urine) monitoring as well as BCM measurement will take place. After 12 weeks of study medication intake, a concluding study visit will be scheduled for final RAS quantification (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM measurement. Initially, blood and urine will be collected at the clinical visit as part of the routine blood obtainment (no additional effort on patients). From these routine measurements we will be able to extract information regarding the patient's current CKD stage as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we will document the patient's current medication and significant comorbidities.
Primary analysis variable/endpoint:
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone
Most important secondary analysis variables/endpoints:
- Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined by mass-spectrometry
- Recurrence of Ang II levels determined by mass-spectrometry
- HDL parameters (protein composition of HDL)
- Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine)
- Urinary electrolyte levels
- Urinary glucose levels
- Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity)
- Blood pressure determined by ambulatory blood pressure measurements
- Body volume determined by bioimpedance fluid status assessment (BCM measurement)
- OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer
- Assessment of reduction of salt sensitivity by using salt sensitivity test with empagliflozin
- Conditions
- Diabetic Kidney Disease, Diabetes Mellitus, Type 2, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- Being tested
- Empagliflozin 10 MG [Jardiance], Placebo Oral Tablet
- Keywords
- Empagliflozin, SGLT-2 Inhibiton and RAS in CKD
- 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.
Empagliflozin 10 MG [Jardiance]Drug
administered orally once daily
Placebo Oral TabletDrug
administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Diabetic CKD patients receiving Empagliflozin 10 MG [Jardiance] Receives: Drug: Empagliflozin 10 MG [Jardiance] |
| Group B | Placebo comparator | Diabetic CKD patients receiving Placebo Oral Tablet Receives: Drug: Placebo Oral Tablet |
| Group C | Experimental | Non-diabetic CKD patients receiving Empagliflozin 10 MG [Jardiance] Receives: Drug: Empagliflozin 10 MG [Jardiance] |
| Group D | Placebo comparator | Non-diabetic CKD patients receiving 'Placebo Oral Tablet Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone
Measured: Visit 2 and Visit 8; 3 months
Secondary outcomes (10)
Mean quantitative changes of baseline multiple RAS effector angiotensin levels after 3 months of empagaliflozin treatment
Mean quantitative changes of baseline multiple RAS effector angiotensin levels after 3 months of empagaliflozin treatment
Measured: Visit 2 and Visit 8; 3 months
Mean changes of baseline Ang II levels after 3 months of empagaliflozin treatment
Mean changes of baseline Ang II levels after 3 months of empagaliflozin treatment
Measured: Visit 2 and Visit 8; : 3 months
Mean changes of baseline specific protein amount on HDL after 3 months of empagaliflozin treatment
Mean changes of baseline specific protein amount on HDL after 3 months of empagaliflozin treatment
Measured: Visit 2 and Visit 8; 3 months
Mean changes in specific renal parameters from baseline in 3 months of empagaliflozin treatment (albuminuria reduction, renal function)
Mean changes in specific renal parameters from baseline in 3 months of empagaliflozin treatment (albuminuria reduction, renal function)
Measured: Visit 2 ,3,4,5,6,7,8; 3 months
Mean changes from baseline relevant blood parameters (HbA1c, β-hydroxybutyrat, elektrolytes, lipids, etc.) after 3 months of empagaliflozin treatment
Mean changes from baseline relevant blood parameters (HbA1c, β-hydroxybutyrat, elektrolytes, lipids, etc.) after 3 months of empagaliflozin treatment
Measured: Visit 2 ,3,4,5,6,7,8; 3 months
Mean changes from baseline urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) after 3 months of empagaliflozin treatment
Mean changes from baseline urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) after 3 months of empagaliflozin treatment
Measured: Visit 2 and Visit 8; 3 months
Mean changes in baseline blood pressure after 3 months of empagaliflozin treatment
Mean changes in baseline blood pressure after 3 months of empagaliflozin treatment
Measured: Visit 2 ,3,4,5,6,7,8; 3 months
Mean changes in body fluid status after 3 months of empagaliflozin treatment
Mean changes in body fluid status after 3 months of empagaliflozin treatment
Measured: Visit 2 and Visit 8; 3 months
Mean changes in baseline oxygen consumption rate (OCR) and the extracellular acidification rate (ECAR) in peripheral peripheral blood mononuclear cells (PBMCs) after 3 months of empagliflozin treatment
Mean changes in baseline oxygen consumption rate (OCR) and the extracellular acidification rate (ECAR) in peripheral peripheral blood mononuclear cells (PBMCs) after 3 months of empagliflozin treatment
Measured: Visit 2 and Visit 8; 3 months
Mean changes in salt sensitivity after 3 months of empagliflozin treatment
Mean changes in salt sensitivity after 3 months of empagliflozin treatment
Measured: Visit 2 and Visit 8; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start15 Apr 2017
- Primary completion18 Jun 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Medical University of ViennaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Attoquant Diagnostics
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Manfred Hecking, MD PhD, Medical University of Vienna
- Investigators
- Manfred Hecking, MD, Principal investigator, Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078101
- Sponsor's protocol ID
- EUDRACT-Nr: 2016-002935-14
- Acronym
- EMPRA
- Status last verified
- Aug 2019
- First submitted
- 7 Mar 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Empagliflozin on the Renin-angiotensin System in Patients With Chronic
- ClinicalTrials.gov ID
- NCT03078101
- Acronym / sponsor ID
- EMPRA / EUDRACT-Nr: 2016-002935-14
- Conditions
- Diabetic Kidney Disease, Diabetes Mellitus, Type 2, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
- Keywords
- Empagliflozin, SGLT-2 Inhibiton and RAS in CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Attoquant Diagnostics
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 13 Mar 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.
This study will be a prospective, clinical pilot study in CKD patients to show whether Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone.
Null and alternative hypotheses:
H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than ACEi treatment alone.
H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone
Methodology:
Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2 diabetes will be randomized into the study medication or placebo group. The number of patients per treatment arms is n = 12. Included and consented patients will be subjected to an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following the 2-week run-in phase, all study patients will be subjected to blood collection including the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently, patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and urine) monitoring as well as BCM measurement will take place. After 12 weeks of study medication intake, a concluding study visit will be scheduled for final RAS quantification (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM measurement. Initially, blood and urine will be collected at the clinical visit as part of the routine blood obtainment (no additional effort on patients). From these routine measurements we will be able to extract information regarding the patient's current CKD stage as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we will document the patient's current medication and significant comorbidities.
Primary analysis variable/endpoint:
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone
Most important secondary analysis variables/endpoints:
- Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined by mass-spectrometry
- Recurrence of Ang II levels determined by mass-spectrometry
- HDL parameters (protein composition of HDL)
- Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine)
- Urinary electrolyte levels
- Urinary glucose levels
- Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity)
- Blood pressure determined by ambulatory blood pressure measurements
- Body volume determined by bioimpedance fluid status assessment (BCM measurement)
- OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer
- Assessment of reduction of salt sensitivity by using salt sensitivity test with empagliflozin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Empagliflozin 10 MG [Jardiance]Diabetic CKD patients receiving Empagliflozin 10 MG [Jardiance] |
| Group B | Placebo comparator | Drug: Placebo Oral TabletDiabetic CKD patients receiving Placebo Oral Tablet |
| Group C | Experimental | Drug: Empagliflozin 10 MG [Jardiance]Non-diabetic CKD patients receiving Empagliflozin 10 MG [Jardiance] |
| Group D | Placebo comparator | Drug: Placebo Oral TabletNon-diabetic CKD patients receiving 'Placebo Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- for CKD patients with type 2 diabetes
- Estimated GFR (calculated with the MDRD-IDMS formula) between 15 and 59 ml/min (with CKD stage IIIa/b to IV)
- Albumin excretion rates of 30-300 mg/24 hours (UACR <300 mg/g)
- Fasting plasma glucose levels >126 mg/dl [7mmol/L] or HbA1c levels >6.5% (Definition of type 2 diabetes according to the diagnostic criteria set forth by the American Diabetes Association in 2009)
- for CKD patients without Diabetes
Key exclusion criteria (16 listed)
- CKD patients with type 2 diabetes
- Age <18 years
- Severely impaired renal function (eGFR <15ml/min)
- Hyperkalemia above 4.5mmol/L
- Hypotension (systolic blood pressure lower than 120 mmHg on ambulatory measurement)
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 |
|---|---|---|
| Empagliflozin 10 MG [Jardiance]administered orally once daily | Drug | Group A, Group C |
| Placebo Oral Tabletadministered orally once daily | Drug | Group B, Group D |
Primary outcome
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone
Time frame: Visit 2 and Visit 8; 3 months
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone
10 secondary outcomes
Mean quantitative changes of baseline multiple RAS effector angiotensin levels after 3 months of empagaliflozin treatment
Time frame: Visit 2 and Visit 8; 3 months
Mean changes of baseline Ang II levels after 3 months of empagaliflozin treatment
Time frame: Visit 2 and Visit 8; : 3 months
Mean changes of baseline specific protein amount on HDL after 3 months of empagaliflozin treatment
Time frame: Visit 2 and Visit 8; 3 months
Mean changes in specific renal parameters from baseline in 3 months of empagaliflozin treatment (albuminuria reduction, renal function)
Time frame: Visit 2 ,3,4,5,6,7,8; 3 months
Mean changes from baseline relevant blood parameters (HbA1c, β-hydroxybutyrat, elektrolytes, lipids, etc.) after 3 months of empagaliflozin treatment
Time frame: Visit 2 ,3,4,5,6,7,8; 3 months
Mean changes from baseline urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) after 3 months of empagaliflozin treatment
Time frame: Visit 2 and Visit 8; 3 months
Mean changes in baseline blood pressure after 3 months of empagaliflozin treatment
Time frame: Visit 2 ,3,4,5,6,7,8; 3 months
Mean changes in body fluid status after 3 months of empagaliflozin treatment
Time frame: Visit 2 and Visit 8; 3 months
Mean changes in baseline oxygen consumption rate (OCR) and the extracellular acidification rate (ECAR) in peripheral peripheral blood mononuclear cells (PBMCs) after 3 months of empagliflozin treatment
Time frame: Visit 2 and Visit 8; 3 months
Mean changes in salt sensitivity after 3 months of empagliflozin treatment
Time frame: Visit 2 and Visit 8; 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Individual participant dataSharing planned: No
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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.
Manfred Hecking, MD principal investigator
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin 10 MG [Jardiance] in people with Diabetic Kidney Disease and Diabetes Mellitus, Type 2, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 8 Aug 2019. 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 Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone (time frame: Visit 2 and Visit 8; 3 months). 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 NCT03078101, which also lists 1 linked publication.
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 8 Aug 2019.