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QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy

ConditionType 2 Diabetic Kidney Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHuijie Zhang

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

820 Participants
are divided into 4 treatment groups
Group A: Group 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placeboExperimental treatment 4 interventions
Group B: Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placeboExperimental treatment 4 interventions
Group C: Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placeboExperimental treatment 4 interventions
Group D: Group 4 (G4): ARB + empagliflozin + mazdutide + finerenoneExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Baseline and Month 6

Secondary outcomes

1

Percentage of Participants Achieving UACR Reductions of ≥30% and ≥50%

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.

Time frame
Baseline and Month 6
2

Regression Rate of Albuminuria Stages

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

Time frame
Baseline and Month 6
3

Relative Change From Baseline in UACR at Day 30

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

Time frame
Baseline and Day 30
4

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

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

Time frame
Baseline and Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huijie Zhang

Lead sponsor

Shanghai Zhongshan Hospital

Sponsor institution

Source ClinicalTrials.gov

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