QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 4

Age range

18 years - 70 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

820 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Huijie Zhang

Study start

Nov 3, 2026 Actual

Primary completion

Feb 28, 2029 Estimated

Study completion

Jun 30, 2029 Estimated

First posted

Aug 20, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts