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Trial · Interventional

Not yet recruitingPhase 4Registry data

QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

Overview

Status
Not yet recruiting
Phase
Phase 4
Enrollment
820 participants (estimated)
Sponsor
Huijie Zhang · Other
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
1 Sept 2026 (estimated)
Primary completion
28 Feb 2029 (estimated)
Completion
30 Jun 2029 (estimated)
First posted
20 Aug 2026
Last update posted
20 Aug 2026
Conditions
Type 2 Diabetic Kidney Disease

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph 4

    QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

    NCT07775846

    est. 1 Sept 2026 to est. 30 Jun 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • empagliflozinDrug
  • FinerenoneDrug
  • MazdutideDrug
  • Finerenone PlaceboDrug
  • Mazdutide PlaceboDrug
  • Angiotensin Receptor Blocker (ARB)Drug

Arms4

  • Experimental

    Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo

  • Experimental

    Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo

  • Experimental

    Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo

  • Experimental

    Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6

    Time frame · Baseline and Month 6

    Registry description

    Relative change of UACR from baseline to Month 6 will be utilized for comparison between the treatment groups.

Secondary outcomes(10)
  1. Percentage of Participants Achieving UACR Reductions of ≥30% and ≥50%

    Time frame · Baseline and Month 6

    Registry description

    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.

  2. Regression Rate of Albuminuria Stages

    Time frame · Baseline and Month 6

    Registry description

    The percentage of participants demonstrating a regression in albuminuria category, including regression from macroalbuminuria to microalbuminuria, or from microalbuminuria to normoalbuminuria.

  3. Relative Change From Baseline in UACR at Day 30

    Time frame · Baseline and Day 30

    Registry description

    Early relative change in UACR to evaluate the short-term response between treatment groups

  4. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Time frame · Baseline and Month 6

    Registry description

    eGFR is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation to monitor renal function progression.

  5. Change From Baseline in Body Weight and Body Mass Index (BMI)

    Time frame · Baseline and Month 6

    Registry description

    Evaluation of the metabolic impact of the multi-drug regimens on body weight (measured in kilograms) and BMI (measured in kg/m²).

  6. Change From Baseline in Hemoglobin A1c (HbA1c) and Fasting Plasma Glucose (FPG)

    Time frame · Baseline and Month 6

    Registry description

    Assessment of glycemic control efficacy across different treatment groups.

  7. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame · Baseline and Month 6

    Registry description

    Evaluation of the blood pressure-lowering effects between different treatment groups.

  8. Change From Baseline in Serum Potassium Levels

    Time frame · Baseline and Month 6

    Registry description

    Monitoring the safety profile regarding potassium homeostasis, particularly concerning the use of the non-steroidal MRA (finerenone).

  9. Incidence of Adverse Events of Special Interest (AESIs)

    Time frame · Through Month 6

    Registry description

    The percentage of participants experiencing predefined adverse events of interest, including hyperkalemia, symptomatic hypotension, urinary tract infections, hypoglycemia, and diabetic ketoacidosis.

  10. Incidence of Acute Kidney Injury (AKI)

    Time frame · Through Month 6

    Registry description

    The percentage of patients who meet the clinical diagnostic criteria for Acute Kidney Injury during the treatment period.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 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). 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.

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