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NephropathyPhase 2EMPA-REINNCT03093103

Empagliflozin and Renal Oxygenation in Healthy Volunteers

A Phase 2 study testing Empagliflozin 10 mg in people with Nephropathy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Nephropathy
What is being tested?
Empagliflozin 10 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteSwitzerland
Study dates
16 Mar 2017to 31 Dec 2018
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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal weight (BMI: 19-24.9kg/m2), overweight (BMI:25-30kg/m2) or obesity (BMI>30kg/m2)
  • Men and women (with a negative pregnancy test) during the follicular phase of the menstrual cycle. All groups will have a balanced number of men and women.
  • OGTT/HbA1C: normal or pre-diabetes
  • eGFR>60ml/min, albumin/creatinine ratio <3.3mg/mmol (<30 mg/g)
  • Signed consent form
  • Normal renal ultrasound
  • Normal urine dipstick

Who cannot join

  • Antihypertensive therapy
  • NSAID treatment
  • Former bariatric surgery
  • Age<18y or >50y
  • At risk of dehydration or hypotension
  • Past history of recurrent genital or urinary tract infections
Show all 9Show fewer
  • Contra-indication for MR imaging (pacemaker or other implanted metallic device, claustrophobia)
  • Pregnancy
  • Sustained systolic blood pressure >150mmHg or diastolic blood pressure >95mmHg

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Service de Néphrologie

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: Effects of the SGLT2 Inhibitor Empagliflozin on Renal Tissue Oxygenation in Non-diabetic Subjects

SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule.

SGLT-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold for renal glucose excretion to lower levels. This effect is independent from insulin. The inhibition of SGLT2 decreases HbA1C, systolic blood pressure and weight in diabetic subjects. Recently, the EMPA-REG trial demonstrated a decrease in cardiovascular mortality and renal endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular disease.

Because this novel hypoglycemic drug has unique and direct effects on renal tissue metabolism, it is important to better examine its effects on the kidney. With this study, we propose to explore the effects of empagliflozin on renal tissue oxygenation. Our hypothesis is that SGLT-2 inhibition decreases renal cortical energy requirements with consequently an increase in renal tissue oxygenation.

Read the detailed description

This study is a double-blind, randomized, placebo-controlled study that will examine the acute and chronic renal effects of empagliflozin in healthy volunteers.

A total of 45 healthy volunteers will be included in the study: 15 normal weight, 15 overweight (BMI: 25-30kg/m2) and 15 obese (BMI>30kg/m2) non diabetic subjects (as determined after an oral glucose tolerance test).

Empagliflozin 10mg vs placebo will be administered in a blinded fashion qd. The acute and chronic renal response to empagliflozin will be assessed.

Conditions
Nephropathy
Being tested
Empagliflozin 10 mg, Placebo
Keywords
empagliflozin, kidney, BOLD-MRI
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 mgDrug

    Also called Jardiance

    Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI

  • PlaceboDrug

    Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI

Study groups in NCT03093103
Study groupRoleWhat they receive
empagliflozin 10mgActive comparatorEmpagliflozin (Jardiance) 10mg is an SGLT-2inhibitor. The drug will be taken qd for 4 weeks.
Receives: Drug: Empagliflozin 10 mg
PlaceboPlacebo comparatorPlacebo will be taken qd for 4 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal oxygenation

    The acute and chronic effect of empagliflozin on renal oxygenation will be assessed by BOLD-MRI

    Measured: 18 months

Secondary outcomes (4)

  1. Acute and chronic effects of empagliflozin on diurnal and nocturnal sodium, potassium, uric acid, calcium, phosphate, glucose and lithium clearances after 4 weeks treatment

    Will be assessed on 24h urinary collections

    Measured: 18 months

  2. Acute and chronic effects of empagliflozin on renal resistance indexes and renal volume after 4 weeks treatment

    Will be assessed by renal ultrasound

    Measured: 18 months

  3. Effects of empagliflozin on 24h blood pressure mesaurements

    WIll be assessed by ambulatory blood pressure measurements

    Measured: 18 months

  4. Effect of body weight on the renal response to empagliflozin

    Different groups of BMI will be evaluated

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start16 Mar 2017
  3. Primary completion30 Dec 2018
  4. Study completion31 Dec 2018

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised placebo-controlled double blind trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093103
Sponsor's protocol ID
2016-00099
Other IDs
2016
Acronym
EMPA-REIN
Status last verified
Jul 2019
First submitted
16 Mar 2017
Last updated
30 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zanchi A, Pruijm M, Muller ME, Ghajarzadeh-Wurzner A, Maillard M, Dufour N, Bonny O, Wuerzner G, Burnier M. Twenty-Four Hour Blood Pressure Response to Empagliflozin and Its Determinants in Normotensive Non-diabetic Subjects. Front Cardiovasc Med. 2022 Mar 22;9:854230. doi: 10.3389/fcvm.2022.854230. eCollection 2022.

    PubMed 35391843

  • Harmacek D, Pruijm M, Burnier M, Muller ME, Ghajarzadeh-Wurzner A, Bonny O, Zanchi A. Empagliflozin Changes Urine Supersaturation by Decreasing pH and Increasing Citrate. J Am Soc Nephrol. 2022 Jun;33(6):1073-1075. doi: 10.1681/ASN.2021111515. Epub 2022 Apr 6.

    PubMed 35387874

  • Zanchi A, Burnier M, Muller ME, Ghajarzadeh-Wurzner A, Maillard M, Loncle N, Milani B, Dufour N, Bonny O, Pruijm M. Acute and Chronic Effects of SGLT2 Inhibitor Empagliflozin on Renal Oxygenation and Blood Pressure Control in Nondiabetic Normotensive Subjects: A Randomized, Placebo-Controlled Trial. J Am Heart Assoc. 2020 Jul 7;9(13):e016173. doi: 10.1161/JAHA.119.016173. Epub 2020 Jun 20.

    PubMed 32567439

  • Muller ME, Pruijm M, Bonny O, Burnier M, Zanchi A. Effects of the SGLT-2 Inhibitor Empagliflozin on Renal Tissue Oxygenation in Non-Diabetic Subjects: A Randomized, Double-Blind, Placebo-Controlled Study Protocol. Adv Ther. 2018 Jun;35(6):875-885. doi: 10.1007/s12325-018-0708-y. Epub 2018 May 25.

    PubMed 29802538

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empagliflozin 10 mg in people with Nephropathy, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

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 9 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 30 Jul 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 Switzerland. 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?

Renal oxygenation (time frame: 18 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 NCT03093103, which also lists 4 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 30 Jul 2019.

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