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EmpaSema

UnknownPhase 4

Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria

Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria - A Double Blinded, Randomised, Placebo Controlled, Parallel, Single Center Study

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

80

estimated

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

eGFR ≥30UACR ≥100

Primary endpoint

UACR, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04061200
Org study ID2019-003175-19

Timeline

Milestones

Study first posted2019-08-19actual
Last update posted2019-08-19actual
Study start2019-11-01estimated
Primary completion2021-07-01estimated
Study completion2021-08-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age100 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Given written informed consent

2. Male or female patients ≥ 18 years with type 2 diabetes (WHO criteria).

3. UACR > 100 mg/g within a year of informed consent documented in the medical files.

4. eGFR ≥ 30 ml/min/1.73 m2 (estimated by CKD-EPI formula) within 3 months of informed consent documented in the medical files. The eGFR measured at visit 0 has to meet the criteria as well.

5. Fertile female must use chemical, hormonal and mechanical contraceptives, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening

6. Treated with maximal tolerated dose of an angiotensin-converting-enzyme inhibitor or an angiotensin II receptor blocker, 4 weeks prior to randomisation. If the participants are not treated with maximal tolerated dosis the investigator will increase the dose 4 weeks prior randomisation if tolerated.

7. Ability to communicate with the investigator and understand informed consent.

Exclusion criteria

1. Type 1 diabetes

2. Known or suspected hypersensitivity to trial product(s) or related products

3. Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial

4. Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months.

5. Previous bowel resection

6. Body mass index < 18.5 kg/m2

7. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods

8. Known or suspected abuse of alcohol or narcotics.

9. Participant in another intervention study

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
3
Renal / kidney
2
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Hba1c

Time frame:From randomisation to week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

2 endpoints
Primary/protocol endpoint

Albuminuria

Time frame:From randomisation to week 52

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

GFR

Time frame:From randomisation to week 52

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

24 hour blood pressure

Time frame:From randomisation to week 52

change from baseline, improvement

Secondary/protocol endpoint

Vasoactive hormones

Time frame:From randomisation to week 52

change from baseline, improvement

componentsplasma renin concentration, plasma renin activity, angiotensin I, angiotensin II, aldosterone, copeptin

Secondary/protocol endpoint

Inflammatory and endothelial biomarkers

Time frame:From randomisation to week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.