Clinical trial for Type 2 Diabetic Kidney Disease
Official title QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
ClinicalTrials.gov ID: NCT07775846
What this study is testing
What is empagliflozin?
empagliflozin is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for type 2 diabetic kidney disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study employs a parallel-controlled design, aiming to enroll adult people with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2.
You likely can't join if
- 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.
See the full eligibility 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...
- 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%.
- Voluntarily understood and signed the written Informed Consent Form (ICF).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.