Chronic kidney disease
Conditions
Interventions
The treatment group:Alisartan240mg/d+Benazepril10mg/d
The control group:Alisartan240mg/d+Placebo10mg/d
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All the following conditions must be met: 1. Sustained low to moderate proteinuria (24-hour proteinuria >= 0.5g/d and = 30ml/min/1.73m2 as calculated by the EPI equation; 2. 120 = 35g/l; 4. Elevated Blood creatinine <= Baseline value 30%; 5. Potassium levels <= 5.5mmol/l; 6. 24-hour proteinuria did not increase compared to baseline.
Exclusion criteria
Exclusion criteria: 1. Patients with type ? or type 2 diabetes; 2. Serum albumin levels 180mmHg or SBP < 120mmHg; 4. Congestive heart failure reached the NYHA's grade IV of cardiac function; 5. The patient has clinically significant concomitant disease: a.Not installed pacemakers II or III degrees heart block; b.With potentially life-threatening arrhythmias or other uncontrolled arrhythmias; c.Valvular heart disease of clinical significance; d.Renal artery stenosis is known; e.Polycystic kidney is known in patients. 6. Life expectancy for any existing life-threatening condition is less than 2 years; 7. There has been a history of any systemic malignancy in the past 5 years, whether or not treated or with evidence of local recurrence or metastasis. Basal cell skin cancer is excluded; 8. Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of the test drug; 9. Has a history of drug or alcohol abuse in the past 12 months; 10. In the investigator's judgment, any condition that may increase the risk to the patient of participating in the trial or may prevent the patient from complying with the requirements or completing the trial; 11. Allergy to or contraindications to any experimental drug; 12. Past inability or unwillingness to follow test protocol; 13. Any situation that may affect safety or effectiveness; 14. Any experimental drugs were used within 30 days or 5 half-lives prior to inclusion; 15. Personnel involved in the implementation of this pilot programme; 16. Has had a previous kidney transplant or is currently receiving immunosuppressive therapy; 17. A woman who is pregnant or breastfeeding. Other fertile women must be postmenopausal, sterilized or using effective contraception; 18. Obese patients with a BMI greater than 35; 19. The doctor judged that the recent use of immunosuppressant is more likely; 20. Develop an intolerant cough associated with the test drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glomerular filtration rate;Glomerular filtration rate slope;Serum creatinine;Collection of renal endpoint information; | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection of cardiovascular endpoint information;24-hour Urine protein ration;24-hour Urinary sodium;Routine urine;Urine sediment microscopic examination;triglycerides;Total cholesterol;High density lipoprotein;Low density lipoprotein;EQ-5D questionnaire;Urea nitrogen;serum albumin;Serum potassium K+; | — |
Countries
China
Contacts
Public ContactJianghua Chen
Kidney Disease Center of the First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed