Trial · Interventional
Not yet recruitingPhase 4Registry dataQUARTET-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
- Ph 4
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
NCT07775846est. 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.
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)
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.
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.
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
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.
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).
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.
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.
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).
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.
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
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