Phase 4: testing empagliflozin for Type 2 Diabetic Kidney Disease
This study employs a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, 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 you would be randomly assigned in a 1:1:1:1 ratio into four treatment groups: Group 1 (G1): ARB + empagliflozin + finerenone dummy treatment (placebo) + mazdutide dummy treatment (placebo); Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide dummy treatment (placebo); Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone dummy treatment (placebo); Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone.
Official registry: https://clinicaltrials.gov/study/NCT07775846 · Huijie Zhang · enrollment listed as 820
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are empagliflozin, Finerenone, or Mazdutide. The registry lists allocation as randomized. This study employs a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria.
They plan to enroll about 820 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)
Interventions: empagliflozin, Finerenone, Mazdutide, Finerenone Placebo, Mazdutide Placebo, Angiotensin Receptor Blocker (ARB)
Primary outcome (registry wording): Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6
Who it is for (from inclusion criteria)
- Ages 18 Years to 70 Years
- 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 (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%
Who the registry excludes
- 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
Public study contact (from the registry)
jingjing jiang, PhD
jiang.jingjing@zs-hospital.sh.cn
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (recruiting)
FAQ about this NCT record
Is NCT07775846 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07775846?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07775846?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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