Quadruple Therapy for Type 2 Diabetic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind trial enrolls adults with type 2 diabetic kidney disease who are on stable ARB or ACE inhibitor therapy. Participants are assigned equally to one of four groups receiving empagliflozin, finerenone, mazdutide, and their placebos in different combinations, along with background ARB therapy. The study aims to determine if triple therapy (empagliflozin plus two additional agents) is superior to dual therapy, and if quadruple therapy offers additional benefit over triple therapy, with UACR as the primary outcome. The trial uses a parallel-controlled design to compare the four regimens and assess safety within this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: jingjing jiang, PhD
• Email: jiang.jingjing@zs-hospital.sh.cn
• Phone: 13402003919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.