Type 2 Diabetic Kidney DiseasePhase 4NCT07775846
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
A Phase 4 study testing empagliflozin, Finerenone and Mazdutide in people with Type 2 Diabetic Kidney Disease, run by Huijie Zhang at 1 site in China.
Trial summary
This study employs a prospective, randomized, double-blind, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetic Kidney Disease
- What is being tested?
- empagliflozin, Finerenone and Mazdutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM).
- Receiving a standard dose of an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) therapy for at least 4 consecutive weeks prior to screening, with the dose expected to remain stable throughout the study period.
- Body Mass Index (BMI) ≥ 24.0 kg/m2.
- Mean urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g and < 5000 mg/g, calculated from first morning void urine samples collected over 3 consecutive days.
- Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2 and ≤ 90 mL/min/1.73m2.
- Serum potassium level ≤ 4.8 mmol/L.
- Glycated hemoglobin (HbA1c) < 11%.
- Voluntarily understood and signed the written Informed Consent Form (ICF).
Who cannot join
- Definite diagnosis of non-diabetic kidney disease (e.g., IgA nephropathy, polycystic kidney disease, lupus nephritis, etc).
- Personal or family history of medullary thyroid carcinoma (MTC), or a diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2).
- History of severe acute or chronic pancreatitis.
- History of diabetic ketoacidosis (DKA).
- Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) < 110 mmHg.
- Refractory hypertension, defined as a resting SBP > 170 mmHg despite the concurrent use of three antihypertensive medications.
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- History of severe dehydration, severe diarrhea, or acute volume depletion within 30 days prior to screening.
- History of acute kidney injury (AKI) within 30 days prior to screening.
- Use of traditional Chinese medicines with potential proteinuria-lowering effects (e.g., Keluoxin capsules, Huangkui capsules, or Shenyan Kangfu tablets) within 30 days prior to screening.
- Use of potassium-sparing diuretics (e.g., triamterene or amiloride) or mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone, or finerenone) within 2 months prior to screening.
- Use of GLP-1 receptor agonists, GLP-1/GIP dual receptor agonists, or GLP-1/glucagon (GCG) dual receptor agonists within 6 months prior to screening.
- Current use of strong CYP3A4 inhibitors (e.g., itraconazole or clarithromycin) or CYP3A4 inducers that may significantly interfere with finerenone metabolism.
- Myocardial infarction, unstable angina, stroke, or hospitalization due to heart failure (NYHA Class III-IV) within 3 months prior to screening.
- Active urogenital tract infection, or a history of urogenital tract infection associated with the prior use of SGLT2 inhibitors.
- Women who are pregnant, planning to become pregnant, or lactating.
- Inability to complete the 6-month follow-up due to general health conditions or geographic relocation.
- Any other condition that, in the opinion of the investigator, renders the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201508
Jingjing JIANG, 86-021-64041990, jiang.jingjing@zs-hospital.sh.cn
Huijie Zhang
About this study
Official title: QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)
This study employs a prospective, randomized, double-blind, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. With an angiotensin receptor blocker (ARB) as the background therapy, all participants will be randomized in a 1:1:1:1 ratio into four treatment groups:
Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo; Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo; Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo; Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone. The primary comparisons include G2 vs. G1, G3 vs. G1, G4 vs. G2, and G4 vs. G3, designed to evaluate the superiority of triple therapy over dual therapy, and quadruple therapy over triple therapy, in reducing the urine albumin-to-creatinine ratio (UACR).
- Conditions
- Type 2 Diabetic Kidney Disease
- Being tested
- empagliflozin, Finerenone, Mazdutide, Finerenone Placebo, Mazdutide Placebo
- Keywords
- SGLT2 inhibitors, Mineralocorticoid receptor antagonists, GLP-1 receptor agonists, Randomized controlled trial, angiotensin II receptor blocker, urinary albumin-to-creatinine ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozinDrug
Oral tablet, administered at a fixed dose of 10 mg once daily for 6 months.
FinerenoneDrug
Oral tablet, taken once daily for 6 months. Initial dose is 10 mg or 20 mg once daily adjusted based on baseline eGFR (20 mg for eGFR >= 60 mL/min/1.73m²; 10 mg for eGFR 30-60 mL/min/1.73m²). Subsequent dose adjustments are guided by serum potassium levels and renal function.
MazdutideDrug
Once-weekly subcutaneous injection for 6 months, following a mandatory dose-escalation schedule: initiated at 2 mg once weekly for 4 weeks, up-titrated to 4 mg once weekly for 4 weeks (if tolerated), and further increased to 6 mg once weekly as the target maintenance dose.
Finerenone PlaceboDrug
Oral tablet matching active finerenone in appearance and scheduling, without active ingredients, taken once daily for 6 months.
Mazdutide PlaceboDrug
Once-weekly subcutaneous injection matching active mazdutide in appearance and scheduling, without active ingredients, for 6 months.
Angiotensin Receptor Blocker (ARB)Drug
Standard background therapy, titrated to a stable dose for at least 4 weeks prior to enrollment and maintained throughout the 6-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo | Experimental | Not described Receives: Drug: empagliflozin; Drug: Finerenone Placebo; Drug: Mazdutide Placebo; Drug: Angiotensin Receptor Blocker (ARB) |
| Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo | Experimental | Not described Receives: Drug: empagliflozin; Drug: Finerenone; Drug: Mazdutide Placebo; Drug: Angiotensin Receptor Blocker (ARB) |
| Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo | Experimental | Not described Receives: Drug: empagliflozin; Drug: Mazdutide; Drug: Finerenone Placebo; Drug: Angiotensin Receptor Blocker (ARB) |
| Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone | Experimental | Not described Receives: Drug: empagliflozin; Drug: Finerenone; Drug: Mazdutide; Drug: Angiotensin Receptor Blocker (ARB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6
Relative change of UACR from baseline to Month 6 will be utilized for comparison between the treatment groups.
Measured: Baseline and Month 6
Secondary outcomes (10)
Percentage of Participants Achieving UACR Reductions of ≥30% and ≥50%
The proportion of patients in each group who achieve a clinical response, defined as a reduction of ≥30% and ≥50% in UACR compared to their respective baseline values.
Measured: Baseline and Month 6
Regression Rate of Albuminuria Stages
The percentage of participants demonstrating a regression in albuminuria category, including regression from macroalbuminuria to microalbuminuria, or from microalbuminuria to normoalbuminuria.
Measured: Baseline and Month 6
Relative Change From Baseline in UACR at Day 30
Early relative change in UACR to evaluate the short-term response between treatment groups
Measured: Baseline and Day 30
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
eGFR is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation to monitor renal function progression.
Measured: Baseline and Month 6
Change From Baseline in Body Weight and Body Mass Index (BMI)
Evaluation of the metabolic impact of the multi-drug regimens on body weight (measured in kilograms) and BMI (measured in kg/m²).
Measured: Baseline and Month 6
Change From Baseline in Hemoglobin A1c (HbA1c) and Fasting Plasma Glucose (FPG)
Assessment of glycemic control efficacy across different treatment groups.
Measured: Baseline and Month 6
Change From Baseline in Systolic Blood Pressure (SBP)
Evaluation of the blood pressure-lowering effects between different treatment groups.
Measured: Baseline and Month 6
Change From Baseline in Serum Potassium Levels
Monitoring the safety profile regarding potassium homeostasis, particularly concerning the use of the non-steroidal MRA (finerenone).
Measured: Baseline and Month 6
Incidence of Adverse Events of Special Interest (AESIs)
The percentage of participants experiencing predefined adverse events of interest, including hyperkalemia, symptomatic hypotension, urinary tract infections, hypoglycemia, and diabetic ketoacidosis.
Measured: Through Month 6
Incidence of Acute Kidney Injury (AKI)
The percentage of patients who meet the clinical diagnostic criteria for Acute Kidney Injury during the treatment period.
Measured: Through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huijie Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huijie Zhang, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775846
- Sponsor's protocol ID
- B2026-375R
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)
- ClinicalTrials.gov ID
- NCT07775846
- Acronym / sponsor ID
- B2026-375R
- Conditions
- Type 2 Diabetic Kidney Disease
- Keywords
- SGLT2 inhibitors, Mineralocorticoid receptor antagonists, GLP-1 receptor agonists, Randomized controlled trial, angiotensin II receptor blocker, urinary albumin-to-creatinine ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Huijie ZhangUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Aug 2026 (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 employs a prospective, randomized, double-blind, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. With an angiotensin receptor blocker (ARB) as the background therapy, all participants will be randomized in a 1:1:1:1 ratio into four treatment groups:
Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo; Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo; Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo; Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone. The primary comparisons include G2 vs. G1, G3 vs. G1, G4 vs. G2, and G4 vs. G3, designed to evaluate the superiority of triple therapy over dual therapy, and quadruple therapy over triple therapy, in reducing the urine albumin-to-creatinine ratio (UACR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo | Experimental | Drug: empagliflozin, Drug: Finerenone Placebo, Drug: Mazdutide Placebo, Drug: Angiotensin Receptor Blocker (ARB) |
| Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo | Experimental | Drug: empagliflozin, Drug: Finerenone, Drug: Mazdutide Placebo, Drug: Angiotensin Receptor Blocker (ARB) |
| Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo | Experimental | Drug: empagliflozin, Drug: Mazdutide, Drug: Finerenone Placebo, Drug: Angiotensin Receptor Blocker (ARB) |
| Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone | Experimental | Drug: empagliflozin, Drug: Finerenone, Drug: Mazdutide, Drug: Angiotensin Receptor Blocker (ARB) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM).
- Receiving a standard dose of an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) therapy for at least 4 consecutive weeks prior to screening, with the dose expected to remain stable throughout the study period.
- Body Mass Index (BMI) ≥ 24.0 kg/m2.
- Mean urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g and < 5000 mg/g, calculated from first morning void urine samples collected over 3 consecutive days.
- Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2 and ≤ 90 mL/min/1.73m2.
Key exclusion criteria (17 listed)
- Definite diagnosis of non-diabetic kidney disease (e.g., IgA nephropathy, polycystic kidney disease, lupus nephritis, etc).
- Personal or family history of medullary thyroid carcinoma (MTC), or a diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2).
- History of severe acute or chronic pancreatitis.
- History of diabetic ketoacidosis (DKA).
- Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) < 110 mmHg.
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 |
|---|---|---|
| empagliflozinOral tablet, administered at a fixed dose of 10 mg once daily for 6 months. | Drug | Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo, Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo, Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo, Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone |
| FinerenoneOral tablet, taken once daily for 6 months. Initial dose is 10 mg or 20 mg once daily adjusted based on baseline eGFR (20 mg for eGFR >= 60 mL/min/1.73m²; 10 mg for eGFR 30-60 mL/min/1.73m²). Subsequent dose adjustments are guided by serum potassium levels and renal function. | Drug | Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo, Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone |
| MazdutideOnce-weekly subcutaneous injection for 6 months, following a mandatory dose-escalation schedule: initiated at 2 mg once weekly for 4 weeks, up-titrated to 4 mg once weekly for 4 weeks (if tolerated), and further increased to 6 mg once weekly as the target maintenance dose. | Drug | Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo, Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone |
| Finerenone PlaceboOral tablet matching active finerenone in appearance and scheduling, without active ingredients, taken once daily for 6 months. | Drug | Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo, Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo |
| Mazdutide PlaceboOnce-weekly subcutaneous injection matching active mazdutide in appearance and scheduling, without active ingredients, for 6 months. | Drug | Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo, Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo |
| Angiotensin Receptor Blocker (ARB)Standard background therapy, titrated to a stable dose for at least 4 weeks prior to enrollment and maintained throughout the 6-month study period. | Drug | Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo, Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo, Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo, Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone |
Primary outcome
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6
Time frame: Baseline and Month 6
Relative change of UACR from baseline to Month 6 will be utilized for comparison between the treatment groups.
10 secondary outcomes
Percentage of Participants Achieving UACR Reductions of ≥30% and ≥50%
Time frame: Baseline and Month 6
Regression Rate of Albuminuria Stages
Time frame: Baseline and Month 6
Relative Change From Baseline in UACR at Day 30
Time frame: Baseline and Day 30
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and Month 6
Change From Baseline in Body Weight and Body Mass Index (BMI)
Time frame: Baseline and Month 6
Change From Baseline in Hemoglobin A1c (HbA1c) and Fasting Plasma Glucose (FPG)
Time frame: Baseline and Month 6
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline and Month 6
Change From Baseline in Serum Potassium Levels
Time frame: Baseline and Month 6
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Through Month 6
Incidence of Acute Kidney Injury (AKI)
Time frame: Through Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing empagliflozin, Finerenone and Mazdutide in people with Type 2 Diabetic Kidney Disease, run by Huijie Zhang at 1 site in China.
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 8 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jingjing jiang, PhD (13402003919, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.