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

Primary Purpose

Renal Insufficiency, Chronic

Status

Terminated

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Benazepril

Losartan

Benazepril+Losartan

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Renal insufficiency, Benazepril, Losartan, combination treatment, Safety

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Renal Division, Nanfang Hospital,Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Benazepril group

Losartan group

Benazepril+Losartan group

Outcomes

Primary Outcome Measures

The proportion of patients with increase in serum potassium ≥6.0 mmol/L.

Secondary Outcome Measures

The proportion of patients with serum creatinine increase >30%

The proportion of patients with drug-related cough

The proportion of patients with hopotension (systolic blood pressure <110 mmHg despite withdrawal of all additional antihypertensive medication)

The proportion of patients with non-fatal cardiovascular events

Full Information

NCT ID

NCT00630708

First Posted

February 28, 2008

Last Updated

April 2, 2016

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00630708

Brief Title

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

Acronym

SDBRAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

Significant differences observed between groups.

Study Start Date

February 2008 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic

Keywords

Renal insufficiency, Benazepril, Losartan, combination treatment, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

309 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Benazepril group

Arm Title

Arm Type

Active Comparator

Arm Description

Losartan group

Arm Title

Arm Type

Active Comparator

Arm Description

Benazepril+Losartan group

Intervention Type

Drug

Intervention Name(s)

Benazepril

Other Intervention Name(s)

Lotensin

Intervention Description

20 mg per day

Intervention Type

Drug

Intervention Name(s)

Losartan

Other Intervention Name(s)

Cozaar

Intervention Description

100 mg per day

Intervention Type

Drug

Intervention Name(s)

Benazepril+Losartan

Other Intervention Name(s)

Lotensin+Cozaar

Intervention Description

combination treatment of 10 mg benazepril and 50 mg losartan per day

Primary Outcome Measure Information:

Title

The proportion of patients with increase in serum potassium ≥6.0 mmol/L.

Time Frame

Every 4 weeks

Secondary Outcome Measure Information:

Title

The proportion of patients with serum creatinine increase >30%

Time Frame

Every 4 weeks

Title

The proportion of patients with drug-related cough

Time Frame

Every 4 weeks

Title

The proportion of patients with hopotension (systolic blood pressure <110 mmHg despite withdrawal of all additional antihypertensive medication)

Time Frame

Every 4 weeks

Title

The proportion of patients with non-fatal cardiovascular events

Time Frame

Every 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fan Fan Hou, M.D.,Ph.D.

Organizational Affiliation

Renal Division, Nanfang Hospital,Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renal Division, Nanfang Hospital,Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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