QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

Conditions

• Type 2 Diabetic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• empagliflozin — DRUG
  Oral tablet, administered at a fixed dose of 10 mg once daily for 6 months.
• Finerenone — DRUG
  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.
• Mazdutide — DRUG
  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 Placebo — DRUG
  Oral tablet matching active finerenone in appearance and scheduling, without active ingredients, taken once daily for 6 months.
• Mazdutide Placebo — DRUG
  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 Details

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).

Key Dates

First listed

Aug 20, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Feb 28, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

820 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 Outcome Measure

Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6 [ Time Frame: Baseline and Month 6 ]

Central Contacts

• jingjing jiang, PhD
  13402003919
  [email protected]