diabetic kidney disease
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes mellitus aged =18 years 2) Clinical diagnosis of CKD meeting the criteria for persistent proteinuria (laboratory evaluation of at least 2 of 3 consecutive morning fasting samples collected), with a urinary albumin-to-creatinine ratio (UACR) =30 mg/g and a glomerular filtration rate (eGFR) =25 ml/min/1.73m2 (calculated using the CKD-EPI formula) 3) Patients with =4 weeks of prior treatment with a maximum tolerated dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) 4) Serum potassium = 5.0 mmol/L at screening
Exclusion criteria
Exclusion criteria: (1) Those with the following medical or surgical history: i) known severe non-diabetic kidney disease, including clinically relevant renal artery stenosis, ii) glycosylated hemoglobin (HbA1C) =12%, iii) uncontrolled arterial blood pressure: mean seated systolic blood pressure (SBP) =170 mmHg or mean seated diastolic blood pressure (DBP) =110 mmHg or mean systolic blood pressure (SBP) <90 mmHg, ?) Clinical diagnosis of chronic heart failure with reduced ejection fraction and persistent symptoms, ?) Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization for worsening of heart failure within 30 days prior to screening, ?) Receiving dialysis for acute renal failure within 12 weeks, ?) Renal transplantation or planning for renal transplantation within 12 months, ?) Addison's disease, ?) Liver function insufficiency classified as Child-Pugh C, and ?) known allergy to study treatment medications. 2) Patients taking the following medications: i) combination with eplerenone, spironolactone, any renin inhibitor, or potassium-preserving diuretic that cannot be discontinued =4 weeks prior to screening; ii) concomitant treatment with an ACEI and ARB that cannot be discontinued due to the study; and iii) combination therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers; 3) Patients with any of the following conditions: i) any other disease or treatment that may make the patient unsuitable for this study and does not allow participation for the entire planned study period (e.g., active malignancy or other disease limiting life expectancy to <12 months); ii) pregnancy or breastfeeding or planning to become pregnant during the study period; and iii) prior (=30 days prior to randomization) or concurrent participation in another clinical trial drug study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR;eGFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum potassium; | — |
Countries
China
Contacts
Public ContactGuijun Qin
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed