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

NCT00630708 | Terminated DMC

• 1 other identifier: Nanfang200803
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Keywords

Renal insufficiency; Benazepril; Losartan; combination treatment; Safety

Outcome Measures

Primary Outcomes (1)

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

  Every 4 weeks

Secondary Outcomes (4)

• The proportion of patients with serum creatinine increase >30%

  Every 4 weeks

• The proportion of patients with drug-related cough

  Every 4 weeks

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

  Every 4 weeks

• The proportion of patients with non-fatal cardiovascular events

  Every 4 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Benazepril group

Drug: Benazepril

2

ACTIVE COMPARATOR

Losartan group

Drug: Losartan

3

ACTIVE COMPARATOR

Benazepril+Losartan group

Drug: Benazepril+Losartan

Interventions

Benazepril DRUG

20 mg per day

Also known as: Lotensin

1

Losartan DRUG

100 mg per day

Also known as: Cozaar

2

Benazepril+Losartan DRUG

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

Also known as: Lotensin+Cozaar

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Renal Division, Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

benazepril; Losartan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Fan Fan Hou, M.D.,Ph.D.

  Renal Division, Nanfang Hospital,Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

CN (1)