Diabetic nephropathy
Conditions
Interventions
A:Combination therapy of amlodipine 5mg and irbesartan 150mg, orally take once for 8 weeks
B:Irbesartan 300mg, orally take once for 8 weeks
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as type 2 diabetes mellitus according to the criteria of ADA, 1997; 2. Diagnosed as diabetic nephropathy according to the criteria of KDOQI, 2007; 3. Aged betweeen 18 and 70 years old; 4. No restrition on gender; 5. With persistent macroalbuminuria: ACR > 300 mg/g, and/or proteinuria > 300 mg/24hrs; and protenuria 30 g/L; 6. GFR > 60ml/min,or seum creatinine 140 mmHg and/or DBP > 90 mmHg before the washout of irbesartan; or the patients need antihypertensive therapy; 8. Stable metabolic control for at least 3 months: HbA1c<8.5%,fasting blood glucose <10mmol/L (controlled by oral hypoglycemic drugs or insulin); 9. Serum potassium 3.5 ~ 5.5 mmol/L; 10. Informed consents obtained.
Exclusion criteria
Exclusion criteria: 1. With conditions that prohibit the use of target drugs, such as renal artery stenosis and solitary kidney; 2. Comined with non-diabetic nephropathy, or have received renal transplantation; 3. Patients with diabetic nephropathy whose BP 160/110 mmHg after the washout of irbesartan; 4. With other conditions that can lead to nephropathy or proteinuria, such as acute/chronic glomerulonephritis, urinary tract stone, urinary tract infections, fever, heart and liver diseases; 5. With severe complications of diabetes, such as diabetic ketoacidosis and diatetic foot; 6. Onset of unstable angina pectoris, myocardial infarction, coronary artery brige operation or percutaneous coronary stenting operation, TIA, stroke, heart function III ~ IV level, valvular heart diseases, hypertrophic cardiomyopathy and pacemaker implantation within 3 months before the trial; 7. Patients that need immunosuppressive therapy; 8. With tumors or cancer; 9. With psychotic disorders that cannot well cooperate; 10. Cannot take oral drugs or have troubles in drugs absorption; 11. With drug dependance or HIV infections; 12. With hepatic insufficiency: TIBL > 35 umol/L or transaminase > 2 times of normal range; 13. Allergic to the drugs used in the trial or with other contradiction to use them; allergic constitution (allergic to two or more drugs or foods); 14. Uncontrolled urinary tract infections; 15. Pregnant or breast-feeding females; 16. Patients that take part in other drugs trials; 17. Expected life span < 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR change rate;Effective rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| GFR;Mortality;ACR;Urine protein in 24 hrs;Metabolic conditions;Blood pressure;PCR;The incidence of heart and cerebral vaslular event; | — |
Countries
China
Contacts
Public ContactPing Fu
Outcome results
None listed