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

This study is currently recruiting participants.
Verified October 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT00630708
First received: February 28, 2008
Last updated: October 29, 2013
Last verified: October 2013

February 28, 2008
October 29, 2013
February 2008
May 2014   (final data collection date for primary outcome measure)
The proportion of patients with increase in serum potassium ≥6.0 mmol/L. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00630708 on ClinicalTrials.gov Archive Site
  • The proportion of patients with serum creatinine increase >30% [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of patients with drug-related cough [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of patients with hopotension (systolic blood pressure <110 mmHg despite withdrawal of all additional antihypertensive medication) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of patients with non-fatal cardiovascular events [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency
Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency

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.

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 insufficiency in the presence or absence of diabetes. Even for advanced chronic renal insufficiency (stage 4 CKD), ACE inhibitors and ARBs can still provide renoprotection. Some clinical studies showed that dual RAS blockage seemed to enhance the antiproteinuric effect compared with single-agent ACE inhibitor or ARB and then improve renal survival. However, in the only one randomized controlled trial investigating the renoprotection of combined ACE inhibitor and ARB for mild or moderate chronic renal insufficiency (the mean creatinine value is 2.9mg/dl), the incidence of hyperkalemia was increased in combination therapy compared with monotherapy. Although increase of hyperkalemia was not statistical significant, it suggested that combination treatment of ACEI and ARB might increase the incidence of hyperkalemia in patients with advanced renal insufficiency. However, it is still undetermined whether combination treatment of ACE inhibitor and ARB is safe as an ACE inhibitor or ARB monotherapy in advanced non-diabetic chronic renal insufficiency (stage 4 CKD). 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Insufficiency, Chronic
  • Drug: Benazepril
    20 mg per day
    Other Name: Lotensin
  • Drug: Losartan
    100 mg per day
    Other Name: Cozaar
  • Drug: Benazepril+Losartan
    combination treatment of 10 mg benazepril and 50 mg losartan per day
    Other Name: Lotensin+Cozaar
  • Active Comparator: 1
    Benazepril group
    Intervention: Drug: Benazepril
  • Active Comparator: 2
    Losartan group
    Intervention: Drug: Losartan
  • Active Comparator: 3
    Benazepril+Losartan group
    Intervention: Drug: Benazepril+Losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
309
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Fan Fan Hou, M.D., Ph.D. 86-20-61641597 ffhou@public.guangzhou.gd.cn
China
 
NCT00630708
Nanfang200803
Yes
Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
Not Provided
Principal Investigator: Fan Fan Hou, M.D.,Ph.D. Renal Division, Nanfang Hospital,Southern Medical University
Nanfang Hospital of Southern Medical University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP