Status:
TERMINATED
Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Renal Insufficiency, Chronic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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.
Detailed Description
Interruption of the renin-angiotensin systerm (RAS) with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) slows the progression of chronic renal insufficien...
Eligibility Criteria
Inclusion
- Serum creatinine concentration of 3.0 to 5.0 mg per deciliter (265 to 442 µmol/L)
- 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
- non-diabetic renal disease
- 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 \[a New York Heart Association class of Ⅲ or Ⅳ\])
- had not received ACE inhibitors or ARBs for at least two weeks before screening
Exclusion
- No history of allergic reaction to drugs, especially ACE inhibitors and/or ARBs
- Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
- Malignant hypertension (blood pressure \>180/120 mm Hg) or blood pressure \<110mm Hg without antihypertensive treatment
- Treatment with drugs affecting serum potassium such as diuretic, β2 receptor blocker et al.
- Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs, especially ciclosporin A
- Myocardial infarction or cerebrovascular accident in the year preceding the trial
- Nephrotic syndrome (albuminaemia less than 25 g/L)
- Renovascular disease or connective-tissue disease
- Obstructive uropathy
- Immediate need for dialysis
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00630708
Start Date
February 1 2008
End Date
March 1 2014
Last Update
April 5 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Renal Division, Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510515