Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Benazepril; Losartan

Criteria

Inclusion Criteria:

1. Serum creatinine concentration of 3.0 to 5.0 mg per deciliter (265 to 442 µmol/L)

2. Creatinine clearance of 15 to 30 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation

3. non-diabetic renal disease

4. Persistent heavier proteinuria (defined by urinary protein excretion of more than 0.3g per day for three or more months without evidence of urinary tract infection or overt heart failure [a New York Heart Association class of Ⅲ or Ⅳ])

5. had not received ACE inhibitors or ARBs for at least two weeks before screening

Exclusion Criteria:

1. No history of allergic reaction to drugs, especially ACE inhibitors and/or ARBs

2. Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)

3. Malignant hypertension (blood pressure >180/120 mm Hg) or blood pressure <110mm Hg without antihypertensive treatment

4. Treatment with drugs affecting serum potassium such as diuretic, β2 receptor blocker et al.

5. Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs, especially ciclosporin A

6. Myocardial infarction or cerebrovascular accident in the year preceding the trial

7. Nephrotic syndrome (albuminaemia less than 25 g/L)

8. Renovascular disease or connective-tissue disease

9. Obstructive uropathy

10. Immediate need for dialysis

11. Pregnancy or breastfeeding