Taking people in ChinaPhase 4

Combining Several Medicines for Kidney Disease Caused by Type 2 Diabetes

Tests empagliflozin, finerenone and mazdutide added to an ARB in adults with diabetic kidney disease.

Key facts

Who runs it: Huijie Zhang
Where: Shanghai, ChinaSee the site
Trial code: NCT07775846
Registry title: QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
Status: Recruiting
Phase: Phase 4
People taking part: 820 people, planned
Started: 3 Nov 2026
Expected to end: 30 Jun 2029
Type of study: Interventional, 4 groups
Treatments tested: empagliflozin
Finerenone
Mazdutide
Finerenone Placebo
Mazdutide Placebo
Angiotensin Receptor Blocker (ARB)
Record updated: 10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes and kidney disease caused by it, who already take an ACEI or ARB medicine and have raised protein in the urine.

Age: 18 to 70 years
Sex: All sexes can join.
Disease stage: Type 2 diabetic kidney disease. Urine albumin-to-creatinine ratio (UACR) of 100 mg/g or more and less than 5000 mg/g (mean of first morning urine on 3 days in a row). eGFR (CKD-EPI) of 30 mL/min/1.73m2 or more. HbA1c below 11% (97 mmol/mol). Serum potassium 4.8 mmol/L or lower. BMI 24.0 kg/m2 or more.
Earlier treatment: Must have taken a standard dose of an ACEI or ARB for at least 4 consecutive weeks before screening, with the dose expected to stay stable. Cannot have used potassium-sparing diuretics or mineralocorticoid receptor antagonists (such as spironolactone, eplerenone or finerenone) in the last 2 months. Cannot have used GLP-1 receptor agonists or GLP-1/GIP or GLP-1/glucagon dual agonists in the last 6 months.

Main reasons for not taking part

Kidney disease from a cause other than diabetes, such as IgA nephropathy or lupus nephritis
Personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia type 2
History of severe pancreatitis or diabetic ketoacidosis
Heart attack, unstable angina, stroke or hospital stay for heart failure (NYHA Class III-IV) in the last 3 months
Pregnant, planning pregnancy or breastfeeding

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

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
Serum potassium level ≤ 4.8 mmol/L
Glycated hemoglobin (HbA1c) < 11%
Voluntarily understood and signed the written Informed Consent Form (ICF)

Who cannot take part

Refractory hypertension, defined as a resting SBP > 170 mmHg despite the concurrent use of three antihypertensive medications
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 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
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)
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
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
Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) < 110 mmHg
Women who are pregnant, planning to become pregnant, or lactating

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

Where in China

Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Jingjing JIANGTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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).

The 4 groups in the trial

Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placeboTreatment being tested
Treatment: empagliflozin, Finerenone Placebo, Mazdutide Placebo, and Angiotensin Receptor Blocker (ARB)
Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placeboTreatment being tested
Treatment: empagliflozin, Finerenone, Mazdutide Placebo, and Angiotensin Receptor Blocker (ARB)
Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placeboTreatment being tested
Treatment: empagliflozin, Mazdutide, Finerenone Placebo, and Angiotensin Receptor Blocker (ARB)
Group 4 (G4): ARB + empagliflozin + mazdutide + finerenoneTreatment being tested
Treatment: empagliflozin, Finerenone, Mazdutide, and Angiotensin Receptor Blocker (ARB)